<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999100</url>
  </required_header>
  <id_info>
    <org_study_id>205920</org_study_id>
    <secondary_id>2016-002672-27</secondary_id>
    <nct_id>NCT02999100</nct_id>
  </id_info>
  <brief_title>Comparison of Inhaled Oxytocin (IH) With Intramuscular (IM) Oxytocin in Pregnant Women and With Intravenous (IV) Oxytocin in Healthy Non-pregnant Women</brief_title>
  <official_title>A Randomized, Open-label Study to Characterize the Pharmacokinetics of Inhaled Oxytocin (GR121619) Compared With IM Oxytocin in Women in the Third Stage of Labour, and With IV Oxytocin in Non-pregnant, Non-lactating Women of Childbearing Potential</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>InVentiv Clinique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Monash University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of&#xD;
      reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study&#xD;
      is being conducted to further assess safety and tolerability of inhaled oxytocin, and to&#xD;
      characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered&#xD;
      as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant&#xD;
      women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active&#xD;
      management of the third stage of labour (after the baby is born). Group 2 will enroll&#xD;
      non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous&#xD;
      (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the&#xD;
      safety and tolerability of IH and IV oxytocin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to reliably measure plasma oxytocin levels during third stage labour, regardless of&#xD;
    administration method (intramuscular or inhaled).&#xD;
  </why_stopped>
  <start_date type="Actual">November 23, 2016</start_date>
  <completion_date type="Actual">March 4, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Plasma Concentration Time Profile of Oxytocin</measure>
    <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin</measure>
    <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin</measure>
    <time_frame>10 minutes post dose Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin</measure>
    <time_frame>20 minutes post dose Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin</measure>
    <time_frame>30 minutes post dose Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin</measure>
    <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin</measure>
    <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Terminal Phase Half-life (t1/2) of Oxytocin</measure>
    <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 37 days</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
    <description>Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Change From Baseline in SBP and DBP</measure>
    <time_frame>Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
    <description>SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Change From Baseline in Heart Rate</measure>
    <time_frame>Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
    <description>Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Absolute Values of Heart Rate</measure>
    <time_frame>Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
    <description>Heart rate was measured in semi-supine position after 5 minutes rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval</measure>
    <time_frame>Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
    <description>Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Number of Participants With Abnormal Respiratory Events</measure>
    <time_frame>Up to Day 37</time_frame>
    <description>Number of participants with abnormal respiratory events has been presented</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Forced Expiratory Volume at 1 Minute (FEV1)</measure>
    <time_frame>Pre dose and 1 hour post dose on Day1</time_frame>
    <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Percent Oxygen in Blood</measure>
    <time_frame>Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose</time_frame>
    <description>Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Absolute Values of Respiration Rate</measure>
    <time_frame>Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose</time_frame>
    <description>Respiration rate was measured in semi-supine position after 5 minutes rest</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Plasma Concentration Time Profile of Oxytocin.</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin</measure>
    <time_frame>10 minutes post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin</measure>
    <time_frame>20 minutes post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin</measure>
    <time_frame>30 minutes post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin</measure>
    <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Number of Participants With Non-SAEs and SAEs</measure>
    <time_frame>Up to 15 days</time_frame>
    <description>An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>30 minutes and 2 hours post dose</time_frame>
    <description>Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Absolute Values of Heart Rate</measure>
    <time_frame>30 minutes and 2 hours post dose</time_frame>
    <description>Heart rate was measured in semi-supine position after 5 minutes rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Absolute Values of Respiration Rate</measure>
    <time_frame>30 minutes and 2 hours post dose</time_frame>
    <description>Respiration rate was measured in semi-supine position after 5 minutes rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Absolute Values of Temperature</measure>
    <time_frame>30 minutes and 2 hours post dose</time_frame>
    <description>Body temperature was measured in semi-supine position after 5 minutes rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in SBP and DBP</measure>
    <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
    <description>SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Heart Rate</measure>
    <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
    <description>Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Respiration Rate</measure>
    <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
    <description>Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Body Temperature</measure>
    <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
    <description>Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin</measure>
    <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1</time_frame>
    <description>Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Group 1 -IH oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 400 micrograms (mcg) IH oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1 -IM oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 10 I.U. IM oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (IH and IV oxytocin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 will enrol healthy, non-pregnant, non-lactating female subjects of childbearing potential, and each subject will participate in 2 dosing sessions. Group 2 will be divided into two cohorts: Cohort A will enrol women on a combined oral contraceptive, and Cohort B will enrol women who are not using a hormonal form of contraceptive. Group 2 subjects will randomized to receive IH oxytocin, and IV oxytocin in a cross fashion. Subjects will be followed up in-person once between 7 days to 21 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IH Oxytocin</intervention_name>
    <description>Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).</description>
    <arm_group_label>Group 1 -IH oxytocin</arm_group_label>
    <arm_group_label>Group 2 (IH and IV oxytocin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IM Oxytocin</intervention_name>
    <description>Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration</description>
    <arm_group_label>Group 1 -IM oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV Oxytocin</intervention_name>
    <description>Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.</description>
    <arm_group_label>Group 2 (IH and IV oxytocin)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ROTAHALER</intervention_name>
    <description>ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin</description>
    <arm_group_label>Group 1 -IH oxytocin</arm_group_label>
    <arm_group_label>Group 2 (IH and IV oxytocin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All Groups:&#xD;
&#xD;
          -  Between 18 and 40 years of age inclusive, at the time of signing the informed consent.&#xD;
&#xD;
          -  Healthy as determined by the investigator or medically qualified designee based on a&#xD;
             medical evaluation including medical history, physical examination, and laboratory&#xD;
             tests as required per protocol.&#xD;
&#xD;
          -  Subject clinical chemistry and haematology values within an acceptable range for the&#xD;
             population recruited and not of abnormal clinical significance. A subject with a&#xD;
             clinical abnormality or laboratory parameter(s) which is/are not specifically listed&#xD;
             in the inclusion or exclusion criteria, outside the reference range for the population&#xD;
             being studied may be included only if the investigator in consultation with the&#xD;
             Medical Monitor (if required) agree and document that the finding is unlikely to&#xD;
             introduce additional risk factors and will not interfere with the study procedures.&#xD;
&#xD;
          -  Adequate peripheral venous access for cannulation.&#xD;
&#xD;
        Group 1 Only:&#xD;
&#xD;
          -  Currently pregnant, with an uncomplicated pregnancy as determined by the investigator&#xD;
             or designee.&#xD;
&#xD;
          -  Estimated date of delivery within 24 weeks of screening.&#xD;
&#xD;
          -  Planned spontaneous vaginal birth and considered by investigator at low risk for post&#xD;
             partum hemorrhage (PPH).&#xD;
&#xD;
          -  Planned birth in between the 37th and 42nd week of pregnancy.&#xD;
&#xD;
          -  Women who qualify for oxytocin as appropriate for active management of TSL and who&#xD;
             agree to have active management.&#xD;
&#xD;
        Group 2 Only:&#xD;
&#xD;
          -  ECG normal, or abnormal and not clinically significant.&#xD;
&#xD;
          -  FEV1 &gt;80% of predicted.&#xD;
&#xD;
          -  Systolic blood pressure &gt;=90 millimeters of mercury (mmHg).&#xD;
&#xD;
          -  Body mass index (BMI) within the range 18 - 32 Kilogram (kg)/square meter (m^2)&#xD;
             (inclusive).&#xD;
&#xD;
          -  Sex-Female.&#xD;
&#xD;
          -  Group 2, Cohort A Only:&#xD;
&#xD;
        A female subject is eligible to participate if she is confirmed to be not pregnant at&#xD;
        screening and on Day 1 (as confirmed by a negative serum or urine human chorionic&#xD;
        gonadotrophin [hCG] test), not lactating, and the following condition applies:&#xD;
&#xD;
        Is of reproductive potential and agrees to use the same combined estrogen and progestogen&#xD;
        oral contraceptive from 3 months prior to the first dose of study medication and until the&#xD;
        follow-up contact.&#xD;
&#xD;
        This method of contraception is only effective when used consistently, correctly and in&#xD;
        accordance with the product label. The investigator is responsible for ensuring that&#xD;
        subjects understand how to properly use their method of contraception&#xD;
&#xD;
          -  Group 2, Cohort B Only:&#xD;
&#xD;
        A female subject is eligible to participate if she is confirmed to be not pregnant at&#xD;
        screening and on Day 1 (as confirmed by a negative serum or urine hCG test), not lactating,&#xD;
        and one of the following conditions applies:&#xD;
&#xD;
        Is of reproductive potential and has been using the same non-hormonal contraceptive method&#xD;
        from 3 months prior to the first dose of study medication and until the follow-up contact.&#xD;
&#xD;
        Would be of reproductive potential, but has undergone bilateral tubal ligation or occlusion&#xD;
        or bilateral salpingectomy at least 12 months prior to first dose of study medication.&#xD;
&#xD;
        Is of reproductive potential with only same sex partners or who are and will continue to be&#xD;
        abstinent from penile-vaginal intercourse on a long term and persistent basis, when this is&#xD;
        their preferred and usual lifestyle. Periodic abstinence (e.g. calendar, ovulation,&#xD;
        symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of&#xD;
        contraception.&#xD;
&#xD;
        These methods of contraception are only effective when used consistently, correctly and in&#xD;
        accordance with the product label. The investigator is responsible for ensuring that&#xD;
        subjects understand how to properly use their method(s) of contraception.&#xD;
&#xD;
        Of Note: Group 2, Cohort B will enrol women of reproductive potential if they agree to use&#xD;
        a nonhormonal contraceptive method from at least one month prior to receiving study drug&#xD;
        and until the follow-up assessment. Although condoms with spermicide are not considered a&#xD;
        highly effective method of contraception, the risk of receiving study drug during pregnancy&#xD;
        is minimal for the following reasons:&#xD;
&#xD;
        Pregnancy testing must be negative at screening and on the first day of dosing. Dosing is&#xD;
        completed no greater than 14 days from the start of dosing. Oxytocin has a well established&#xD;
        rapid half-life. If a patient happened to conceive during the time of dosing, study drug&#xD;
        would be eliminated before implantation would occur.&#xD;
&#xD;
          -  All Groups: Capable of giving signed informed consent as described in Protocol which&#xD;
             includes compliance with the requirements and restrictions listed in the consent form&#xD;
             and in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All Groups:&#xD;
&#xD;
          -  Postmenopausal as defined by gynaecological history.&#xD;
&#xD;
          -  Chronic lung condition of any etiology including asthma, Chronic obstructive pulmonary&#xD;
             disease (COPD), emphysema, interstitial lung disease or active Tuberculosis (TB).&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  Blood pressure &gt;140 systolic or &gt;90 diastolic.&#xD;
&#xD;
        Group 1 Only:&#xD;
&#xD;
          -  Females with planned Caesarean Section.&#xD;
&#xD;
          -  Females with significant medical complications as determined by investigator.&#xD;
&#xD;
        Group 2 Only:&#xD;
&#xD;
          -  Currently breastfeeding or lactating.&#xD;
&#xD;
          -  QT duration corrected for heart rate by Fridericia's formula (QTcF) &gt;450 milliseconds&#xD;
             (msec).&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and bilirubin &gt;1.5 Upper Limit of Normal (ULN)&#xD;
             (isolated bilirubin &gt;1.5xULN is acceptable if bilirubin is fractionated and direct&#xD;
             bilirubin &lt;35%).&#xD;
&#xD;
          -  Subjects with highly-active or symptomatic gynaecological disorders (such as large&#xD;
             symptomatic fibroids).&#xD;
&#xD;
        All Groups:&#xD;
&#xD;
          -  Prescription or non-prescription drugs not approved by the investigator.&#xD;
&#xD;
          -  Oxytocin for any reason (including, but not limited to, induction or augmentation of&#xD;
             labour) prior to administration of study-related oxytocin.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as: An&#xD;
             average weekly intake of &gt;14 units. One unit is equivalent to 8 grams (g) of alcohol:&#xD;
             a half-pint (approximately 240 milliliter [ml]) of beer, 1 glass (125 ml) of wine or 1&#xD;
             (25 ml) measure of spirits.&#xD;
&#xD;
          -  Current smokers or subjects with a history of smoking within 6 months of screening, or&#xD;
             with a total pack year history of &gt;5 pack years. Confirmatory use via a Smokerlyzer is&#xD;
             at the discretion of the local investigator, but is advised if the subject's recent&#xD;
             smoking history is in doubt.&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof, or a&#xD;
             history of drug or other allergy that, in the opinion of the investigator or Medical&#xD;
             Monitor, contraindicates their participation (e.g. allergy to any previous inhaler&#xD;
             use).&#xD;
&#xD;
          -  Participation in another clinical trial, which in the opinion of the investigator,&#xD;
             jeopardizes the subject's safety or study outcomes.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 mL within 56 days.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigation&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 30 days or twice the duration of the biological effect of the investigational&#xD;
             product (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
&#xD;
        Group 2 Only:&#xD;
&#xD;
          -  Presence of hepatitis B surface antigen or positive hepatitis C antibody test result.&#xD;
&#xD;
          -  A positive Human Immunodeficiency Virus (HIV) antibody test.&#xD;
&#xD;
          -  A positive pre-study drugs of abuse test (not explained by diet or approved&#xD;
             concomitant medications).&#xD;
&#xD;
          -  A positive alcohol breath test.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 2GG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 2GG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>February 18, 2020</results_first_submitted>
  <results_first_submitted_qc>February 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 5, 2020</results_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oxytocin</keyword>
  <keyword>non-pregnant</keyword>
  <keyword>pregnant</keyword>
  <keyword>Postpartum Hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02999100/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT02999100/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This is a 2 part study: Part 1 enrolled pregnant women, randomized to receive either inhaled (IH) or intramuscular (IM) oxytocin as active management of the third stage of labor. Part 2 enrolled non-pregnant women of childbearing potential and received IH oxytocin and intravenous (IV) oxytocin in a cross over design.</recruitment_details>
      <pre_assignment_details>A total of 31 participants were enrolled in the study. This study was terminated due to inability to reliably measure plasma oxytocin levels in women in third stage labor, regardless of administration method (IH, IM or IV).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>400 mcg Oxytocin IH</title>
          <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
        </group>
        <group group_id="P2">
          <title>17 mcg Oxytocin IM</title>
          <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
        </group>
        <group group_id="P3">
          <title>Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV</title>
          <description>Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="P4">
          <title>Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH</title>
          <description>Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="P5">
          <title>400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV</title>
          <description>Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="P6">
          <title>8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH</title>
          <description>Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1 (up to 15 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2 (Day 1): Dosing Session 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants from Part 1 did not enter Part 2</participants>
                <participants group_id="P2" count="0">Participants from Part 1 did not enter Part 2</participants>
                <participants group_id="P3" count="5">New participants were enrolled in Part 2 of study</participants>
                <participants group_id="P4" count="3">New participants were enrolled in Part 2 of study</participants>
                <participants group_id="P5" count="3">New participants were enrolled in Part 2 of study</participants>
                <participants group_id="P6" count="3">New participants were enrolled in Part 2 of study</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2 (Day 14): Dosing Session 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>400 mcg Oxytocin IH</title>
          <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
        </group>
        <group group_id="B2">
          <title>17 mcg Oxytocin IM</title>
          <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Contraceptives+400 mcg Oxytocin IH, Then 8.5mcg Oxytocin IV</title>
          <description>Healthy participants of childbearing potential were administered oral contraceptive along with 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="B4">
          <title>Contraceptives+8.5mcg Oxytocin IV, Then 400 mcg Oxytocin IH</title>
          <description>Healthy participants of childbearing potential were administered oral contraceptives along with 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="B5">
          <title>400 mcg Oxytocin IH, Then 8.5 mcg Oxytocin IV</title>
          <description>Healthy participants of childbearing potential were administered 400 mcg oxytocin IH during Session 1 and received 8.5 mcg oxytocin IV during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="B6">
          <title>8.5 mcg Oxytocin IV, Then 400 mcg Oxytocin IH</title>
          <description>Healthy participants of childbearing potential were administered 8.5 mcg oxytocin IV during Session 1 and received 400 mcg oxytocin IH during Session 2. Participants were followed up in-person or via telephone within 7 days and no greater than 21 days after last study drug administration.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" spread="3.49"/>
                    <measurement group_id="B2" value="28.1" spread="5.84"/>
                    <measurement group_id="B3" value="24.0" spread="4.53"/>
                    <measurement group_id="B4" value="30.7" spread="0.58"/>
                    <measurement group_id="B5" value="37.3" spread="1.53"/>
                    <measurement group_id="B6" value="27.7" spread="6.66"/>
                    <measurement group_id="B7" value="29.6" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Plasma Concentration Time Profile of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1</time_frame>
        <population>Pharmacokinetic Population includes all participants in Safety population for whom a pharmacokinetic sample was obtained &amp; analysed.Safety Population includes participants who received at least one dose of study medication.Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles)</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Plasma Concentration Time Profile of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population includes all participants in Safety population for whom a pharmacokinetic sample was obtained &amp; analysed.Safety Population includes participants who received at least one dose of study medication.Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles)</population>
          <units>Picograms per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose; n=9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="5.32"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 minutes post dose; n= 7, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="33.54"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes post dose; n=8, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.020" lower_limit="0.00" upper_limit="35.96"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 minutes post dose; n=7, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="24.58"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post dose; n=8, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="13.67"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes post dose; n=8, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="8.70"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post dose; n=8, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="8.46"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="3.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour post dose; n=8, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours post dose; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.5 hours post dose; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="3.54"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 hours post dose; n=8, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours post dose; n=8, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Picograms per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.460" lower_limit="NA" upper_limit="35.96">NA indicates that lower range could not be calculated due to high proportion of non-quantifiable [NQ] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="4.50">NA indicates that median and lower range could not be calculated due to high proportion of non-quantifiable [NQ] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>10 minutes post dose Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Picogram per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="24.58">NA indicates that median and lower range could not be calculated as values at specified time points (10 minutes post-dose) were below the limit of quantification.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="4.50">NA indicates that median and lower range could not be calculated as values at specified time points (10 minutes post-dose) were below the limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>20 minutes post dose Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Picogram per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="8.70">NA indicates that median and lower range could not be calculated as values at specified time points (20 minutes post-dose) were below the limit of quantification.</measurement>
                    <measurement group_id="O2" value="1.960" lower_limit="NA" upper_limit="3.19">NA indicates that lower range could not be calculated as values at specified time points (20 minutes post-dose) were below the limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>30 minutes post dose Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Picogram per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="8.46">NA indicates that median and lower range could not be calculated as values at specified time points (30 minutes post-dose) were below the limit of quantification.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="3.53">NA indicates that median and lower range could not be calculated as values at specified time points (30 minutes post-dose) were below the limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15000" lower_limit="0.0500" upper_limit="2.5000"/>
                    <measurement group_id="O2" value="0.25000" lower_limit="0.1667" upper_limit="0.4833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Hour*picogram per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="8.1">NA indicates that median and lower range could not be calculated due to high proportion of non-quantifiable [NQ] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="2.3">NA indicates that median and lower range could not be calculated due to high proportion of non-quantifiable [NQ] values (more than 50% of values were imputed i.e., NQ assigned zero concentration) which affected the calculation.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Terminal Phase Half-life (t1/2) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.</description>
        <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Terminal Phase Half-life (t1/2) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">NA indicates that data could not be calculated as all values in terminal elimination phase were below the limit of quantification.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">NA indicates that data could not be calculated as all values in terminal elimination phase were below the limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.</description>
        <time_frame>Up to 37 days</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.</description>
        <time_frame>Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP: Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.1" spread="5.24"/>
                    <measurement group_id="O2" value="116.0" spread="12.73"/>
                    <measurement group_id="O3" value="102.0" spread="5.66"/>
                    <measurement group_id="O4" value="105.4" spread="10.11"/>
                    <measurement group_id="O5" value="99.0" spread="NA">NA indicates that standard deviation (SD) could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="107.2" spread="6.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.0" spread="6.16"/>
                    <measurement group_id="O2" value="118.2" spread="9.76"/>
                    <measurement group_id="O3" value="103.5" spread="9.19"/>
                    <measurement group_id="O4" value="108.4" spread="10.71"/>
                    <measurement group_id="O5" value="104.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="110.6" spread="15.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.9" spread="3.29"/>
                    <measurement group_id="O2" value="114.6" spread="9.40"/>
                    <measurement group_id="O3" value="106.0" spread="5.66"/>
                    <measurement group_id="O4" value="106.4" spread="9.50"/>
                    <measurement group_id="O5" value="98.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="106.0" spread="10.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.6" spread="4.04"/>
                    <measurement group_id="O2" value="111.2" spread="6.87"/>
                    <measurement group_id="O3" value="107.0" spread="8.49"/>
                    <measurement group_id="O4" value="113.2" spread="12.05"/>
                    <measurement group_id="O5" value="100.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="104.6" spread="10.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.9" spread="6.26"/>
                    <measurement group_id="O2" value="111.4" spread="5.37"/>
                    <measurement group_id="O3" value="103.5" spread="2.12"/>
                    <measurement group_id="O4" value="108.8" spread="8.64"/>
                    <measurement group_id="O5" value="98.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="109.0" spread="12.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.9" spread="5.11"/>
                    <measurement group_id="O2" value="111.4" spread="11.28"/>
                    <measurement group_id="O3" value="106.5" spread="3.54"/>
                    <measurement group_id="O4" value="102.0" spread="9.41"/>
                    <measurement group_id="O5" value="93.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="106.4" spread="3.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.1" spread="5.93"/>
                    <measurement group_id="O2" value="62.4" spread="7.54"/>
                    <measurement group_id="O3" value="67.0" spread="1.41"/>
                    <measurement group_id="O4" value="62.0" spread="6.36"/>
                    <measurement group_id="O5" value="58.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="64.2" spread="8.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.1" spread="7.67"/>
                    <measurement group_id="O2" value="67.0" spread="8.15"/>
                    <measurement group_id="O3" value="61.5" spread="7.78"/>
                    <measurement group_id="O4" value="65.2" spread="3.03"/>
                    <measurement group_id="O5" value="67.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="60.4" spread="5.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" spread="5.62"/>
                    <measurement group_id="O2" value="64.8" spread="7.43"/>
                    <measurement group_id="O3" value="65.5" spread="4.95"/>
                    <measurement group_id="O4" value="65.6" spread="3.36"/>
                    <measurement group_id="O5" value="68.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="62.4" spread="5.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.3" spread="6.07"/>
                    <measurement group_id="O2" value="65.2" spread="3.11"/>
                    <measurement group_id="O3" value="66.5" spread="4.95"/>
                    <measurement group_id="O4" value="69.6" spread="6.73"/>
                    <measurement group_id="O5" value="70.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="63.0" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.9" spread="4.85"/>
                    <measurement group_id="O2" value="65.8" spread="3.56"/>
                    <measurement group_id="O3" value="69.0" spread="5.66"/>
                    <measurement group_id="O4" value="66.6" spread="2.41"/>
                    <measurement group_id="O5" value="65.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="66.4" spread="9.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.4" spread="7.57"/>
                    <measurement group_id="O2" value="61.6" spread="6.99"/>
                    <measurement group_id="O3" value="64.5" spread="9.19"/>
                    <measurement group_id="O4" value="60.0" spread="6.52"/>
                    <measurement group_id="O5" value="62.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="59.2" spread="5.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Change From Baseline in SBP and DBP</title>
        <description>SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in SBP and DBP</title>
          <description>SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP: 5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="6.47"/>
                    <measurement group_id="O2" value="2.2" spread="13.42"/>
                    <measurement group_id="O3" value="1.5" spread="3.54"/>
                    <measurement group_id="O4" value="3.0" spread="10.42"/>
                    <measurement group_id="O5" value="5.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="3.4" spread="10.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="3.25"/>
                    <measurement group_id="O2" value="-1.4" spread="14.67"/>
                    <measurement group_id="O3" value="4.0" spread="0.00"/>
                    <measurement group_id="O4" value="1.0" spread="11.02"/>
                    <measurement group_id="O5" value="-1.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-1.2" spread="6.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="2.07"/>
                    <measurement group_id="O2" value="-4.8" spread="13.35"/>
                    <measurement group_id="O3" value="5.0" spread="2.83"/>
                    <measurement group_id="O4" value="7.8" spread="12.56"/>
                    <measurement group_id="O5" value="1.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-2.6" spread="7.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="4.27"/>
                    <measurement group_id="O2" value="-4.6" spread="14.10"/>
                    <measurement group_id="O3" value="1.5" spread="3.54"/>
                    <measurement group_id="O4" value="3.4" spread="13.54"/>
                    <measurement group_id="O5" value="-1.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="1.8" spread="9.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="3.82"/>
                    <measurement group_id="O2" value="-4.6" spread="13.79"/>
                    <measurement group_id="O3" value="4.5" spread="2.12"/>
                    <measurement group_id="O4" value="-3.4" spread="9.29"/>
                    <measurement group_id="O5" value="-6.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-0.8" spread="7.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="10.69"/>
                    <measurement group_id="O2" value="4.6" spread="3.58"/>
                    <measurement group_id="O3" value="-5.5" spread="9.19"/>
                    <measurement group_id="O4" value="3.2" spread="6.46"/>
                    <measurement group_id="O5" value="9.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-3.8" spread="3.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="6.92"/>
                    <measurement group_id="O2" value="2.4" spread="7.70"/>
                    <measurement group_id="O3" value="-1.5" spread="6.36"/>
                    <measurement group_id="O4" value="3.6" spread="4.28"/>
                    <measurement group_id="O5" value="10.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-1.8" spread="5.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="7.88"/>
                    <measurement group_id="O2" value="2.8" spread="8.04"/>
                    <measurement group_id="O3" value="-0.5" spread="6.36"/>
                    <measurement group_id="O4" value="7.6" spread="9.94"/>
                    <measurement group_id="O5" value="12.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-1.2" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="3.35"/>
                    <measurement group_id="O2" value="3.4" spread="6.54"/>
                    <measurement group_id="O3" value="2.0" spread="7.07"/>
                    <measurement group_id="O4" value="4.6" spread="3.97"/>
                    <measurement group_id="O5" value="7.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="2.2" spread="2.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="8.20"/>
                    <measurement group_id="O2" value="-0.8" spread="4.97"/>
                    <measurement group_id="O3" value="-2.5" spread="10.61"/>
                    <measurement group_id="O4" value="-2.0" spread="3.24"/>
                    <measurement group_id="O5" value="4.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-5.0" spread="6.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Change From Baseline in Heart Rate</title>
        <description>Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Heart Rate</title>
          <description>Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="6.99"/>
                    <measurement group_id="O2" value="13.8" spread="11.86"/>
                    <measurement group_id="O3" value="19.5" spread="3.54"/>
                    <measurement group_id="O4" value="7.4" spread="13.05"/>
                    <measurement group_id="O5" value="-7.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="13.0" spread="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="11.51"/>
                    <measurement group_id="O2" value="4.4" spread="9.4"/>
                    <measurement group_id="O3" value="7" spread="7.07"/>
                    <measurement group_id="O4" value="2.6" spread="12.44"/>
                    <measurement group_id="O5" value="-7.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="0.6" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="7.29"/>
                    <measurement group_id="O2" value="1.2" spread="11.34"/>
                    <measurement group_id="O3" value="1" spread="1.41"/>
                    <measurement group_id="O4" value="-3.6" spread="11.74"/>
                    <measurement group_id="O5" value="-9.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="-0.2" spread="4.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" spread="7.15"/>
                    <measurement group_id="O2" value="2.2" spread="8.56"/>
                    <measurement group_id="O3" value="4.5" spread="6.36"/>
                    <measurement group_id="O4" value="-1.4" spread="10.04"/>
                    <measurement group_id="O5" value="-10.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="0.2" spread="3.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="6.49"/>
                    <measurement group_id="O2" value="5.8" spread="11.5"/>
                    <measurement group_id="O3" value="9" spread="22.63"/>
                    <measurement group_id="O4" value="6.2" spread="5.4"/>
                    <measurement group_id="O5" value="-6.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="5.8" spread="3.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Absolute Values of Heart Rate</title>
        <description>Heart rate was measured in semi-supine position after 5 minutes rest</description>
        <time_frame>Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Absolute Values of Heart Rate</title>
          <description>Heart rate was measured in semi-supine position after 5 minutes rest</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.1" spread="15.29"/>
                    <measurement group_id="O2" value="65.2" spread="5.93"/>
                    <measurement group_id="O3" value="63.5" spread="21.92"/>
                    <measurement group_id="O4" value="65" spread="9.3"/>
                    <measurement group_id="O5" value="81.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="63.6" spread="13.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" spread="15.01"/>
                    <measurement group_id="O2" value="79" spread="8.15"/>
                    <measurement group_id="O3" value="83" spread="18.38"/>
                    <measurement group_id="O4" value="72.4" spread="14.1"/>
                    <measurement group_id="O5" value="74.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="76.6" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" spread="10.31"/>
                    <measurement group_id="O2" value="69.6" spread="5.64"/>
                    <measurement group_id="O3" value="70.5" spread="14.85"/>
                    <measurement group_id="O4" value="67.6" spread="11.93"/>
                    <measurement group_id="O5" value="74.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="64.2" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" spread="9.32"/>
                    <measurement group_id="O2" value="66.4" spread="6.47"/>
                    <measurement group_id="O3" value="64.5" spread="23.33"/>
                    <measurement group_id="O4" value="61.4" spread="7.96"/>
                    <measurement group_id="O5" value="72.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="63.4" spread="13.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3" spread="10.59"/>
                    <measurement group_id="O2" value="67.4" spread="4.67"/>
                    <measurement group_id="O3" value="68" spread="15.56"/>
                    <measurement group_id="O4" value="63.6" spread="11.24"/>
                    <measurement group_id="O5" value="71.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="63.8" spread="13.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3" spread="13.21"/>
                    <measurement group_id="O2" value="71" spread="5.7"/>
                    <measurement group_id="O3" value="72.5" spread="0.71"/>
                    <measurement group_id="O4" value="71.2" spread="5.54"/>
                    <measurement group_id="O5" value="75.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="69.4" spread="15.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval</title>
        <description>Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.</description>
        <time_frame>Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval</title>
          <description>Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR interval: Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.9" spread="23.67"/>
                    <measurement group_id="O2" value="156.0" spread="22.17"/>
                    <measurement group_id="O3" value="146.5" spread="21.92"/>
                    <measurement group_id="O4" value="139.8" spread="23.67"/>
                    <measurement group_id="O5" value="127.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="139.6" spread="28.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 2 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.6" spread="25.36"/>
                    <measurement group_id="O2" value="158.4" spread="24.13"/>
                    <measurement group_id="O3" value="146.5" spread="14.85"/>
                    <measurement group_id="O4" value="140.0" spread="27.70"/>
                    <measurement group_id="O5" value="125.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="147.0" spread="30.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 10 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.9" spread="27.90"/>
                    <measurement group_id="O2" value="161.6" spread="24.77"/>
                    <measurement group_id="O3" value="143.0" spread="21.21"/>
                    <measurement group_id="O4" value="146.2" spread="28.65"/>
                    <measurement group_id="O5" value="128.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="146.0" spread="31.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 20 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.1" spread="29.59"/>
                    <measurement group_id="O2" value="161.2" spread="26.40"/>
                    <measurement group_id="O3" value="143.5" spread="20.51"/>
                    <measurement group_id="O4" value="147.4" spread="28.61"/>
                    <measurement group_id="O5" value="125.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="151.0" spread="32.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.4" spread="28.96"/>
                    <measurement group_id="O2" value="158.8" spread="25.03"/>
                    <measurement group_id="O3" value="147.0" spread="14.14"/>
                    <measurement group_id="O4" value="146.0" spread="24.37"/>
                    <measurement group_id="O5" value="128.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="151.8" spread="30.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.4" spread="28.92"/>
                    <measurement group_id="O2" value="160.4" spread="22.88"/>
                    <measurement group_id="O3" value="147.5" spread="13.44"/>
                    <measurement group_id="O4" value="146.8" spread="27.65"/>
                    <measurement group_id="O5" value="129.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="150.0" spread="28.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR interval: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153.1" spread="23.43"/>
                    <measurement group_id="O2" value="155.8" spread="25.80"/>
                    <measurement group_id="O3" value="145.5" spread="16.26"/>
                    <measurement group_id="O4" value="141.6" spread="21.09"/>
                    <measurement group_id="O5" value="117.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="139.4" spread="29.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.4" spread="8.20"/>
                    <measurement group_id="O2" value="89.0" spread="5.52"/>
                    <measurement group_id="O3" value="99.0" spread="7.07"/>
                    <measurement group_id="O4" value="91.4" spread="8.85"/>
                    <measurement group_id="O5" value="94.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="89.0" spread="9.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 2 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" spread="7.11"/>
                    <measurement group_id="O2" value="89.4" spread="5.68"/>
                    <measurement group_id="O3" value="104.0" spread="4.24"/>
                    <measurement group_id="O4" value="90.4" spread="9.32"/>
                    <measurement group_id="O5" value="91.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="86.8" spread="6.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 10 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" spread="11.01"/>
                    <measurement group_id="O2" value="91.2" spread="5.67"/>
                    <measurement group_id="O3" value="98.5" spread="9.19"/>
                    <measurement group_id="O4" value="91.2" spread="9.18"/>
                    <measurement group_id="O5" value="91.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="89.2" spread="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 20 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.7" spread="8.96"/>
                    <measurement group_id="O2" value="87.8" spread="4.15"/>
                    <measurement group_id="O3" value="91.0" spread="18.38"/>
                    <measurement group_id="O4" value="90.2" spread="9.55"/>
                    <measurement group_id="O5" value="92.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="89.0" spread="11.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS duration: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3" spread="9.27"/>
                    <measurement group_id="O2" value="89.2" spread="5.22"/>
                    <measurement group_id="O3" value="100.0" spread="0.00"/>
                    <measurement group_id="O4" value="93.4" spread="8.88"/>
                    <measurement group_id="O5" value="93.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="92.2" spread="10.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" spread="8.15"/>
                    <measurement group_id="O2" value="89.6" spread="4.83"/>
                    <measurement group_id="O3" value="99.0" spread="1.41"/>
                    <measurement group_id="O4" value="93.2" spread="9.34"/>
                    <measurement group_id="O5" value="91.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="89.4" spread="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" spread="9.52"/>
                    <measurement group_id="O2" value="88.6" spread="3.21"/>
                    <measurement group_id="O3" value="106.0" spread="8.49"/>
                    <measurement group_id="O4" value="89.0" spread="6.04"/>
                    <measurement group_id="O5" value="92.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="90.0" spread="6.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="401.7" spread="11.84"/>
                    <measurement group_id="O2" value="406.0" spread="19.51"/>
                    <measurement group_id="O3" value="406.5" spread="7.78"/>
                    <measurement group_id="O4" value="413.8" spread="12.15"/>
                    <measurement group_id="O5" value="416.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="411.6" spread="9.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: 2 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403.0" spread="22.02"/>
                    <measurement group_id="O2" value="422.6" spread="21.51"/>
                    <measurement group_id="O3" value="432.5" spread="20.51"/>
                    <measurement group_id="O4" value="420.6" spread="12.50"/>
                    <measurement group_id="O5" value="426.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="427.4" spread="19.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: 10 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407.0" spread="11.18"/>
                    <measurement group_id="O2" value="430.2" spread="20.23"/>
                    <measurement group_id="O3" value="413.5" spread="13.44"/>
                    <measurement group_id="O4" value="422.6" spread="13.15"/>
                    <measurement group_id="O5" value="421.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="412.8" spread="8.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: 20 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407.0" spread="14.87"/>
                    <measurement group_id="O2" value="415.2" spread="26.22"/>
                    <measurement group_id="O3" value="419.5" spread="16.26"/>
                    <measurement group_id="O4" value="422.0" spread="8.28"/>
                    <measurement group_id="O5" value="408.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="416.6" spread="16.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="406.4" spread="13.96"/>
                    <measurement group_id="O2" value="420.2" spread="15.96"/>
                    <measurement group_id="O3" value="411.0" spread="19.80"/>
                    <measurement group_id="O4" value="424.6" spread="8.20"/>
                    <measurement group_id="O5" value="413.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="417.0" spread="15.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="408.3" spread="11.90"/>
                    <measurement group_id="O2" value="416.0" spread="20.76"/>
                    <measurement group_id="O3" value="422.5" spread="0.71"/>
                    <measurement group_id="O4" value="420.2" spread="5.22"/>
                    <measurement group_id="O5" value="418.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="416.2" spread="18.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410.4" spread="10.63"/>
                    <measurement group_id="O2" value="409.2" spread="17.63"/>
                    <measurement group_id="O3" value="420.5" spread="2.12"/>
                    <measurement group_id="O4" value="408.2" spread="22.92"/>
                    <measurement group_id="O5" value="410.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="415.6" spread="12.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="413.2" spread="20.41"/>
                    <measurement group_id="O2" value="408.8" spread="24.01"/>
                    <measurement group_id="O3" value="413.8" spread="26.37"/>
                    <measurement group_id="O4" value="420.4" spread="16.10"/>
                    <measurement group_id="O5" value="441.7" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="418.4" spread="17.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: 2 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="422.3" spread="30.97"/>
                    <measurement group_id="O2" value="453.4" spread="26.42"/>
                    <measurement group_id="O3" value="464.4" spread="8.95"/>
                    <measurement group_id="O4" value="443.1" spread="20.62"/>
                    <measurement group_id="O5" value="460.9" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="453.5" spread="30.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: 10 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="421.3" spread="16.19"/>
                    <measurement group_id="O2" value="443.8" spread="22.71"/>
                    <measurement group_id="O3" value="429.0" spread="1.98"/>
                    <measurement group_id="O4" value="434.1" spread="25.91"/>
                    <measurement group_id="O5" value="439.1" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="421.7" spread="18.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: 20 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416.0" spread="20.89"/>
                    <measurement group_id="O2" value="421.8" spread="29.04"/>
                    <measurement group_id="O3" value="425.5" spread="2.54"/>
                    <measurement group_id="O4" value="432.9" spread="17.19"/>
                    <measurement group_id="O5" value="418.4" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="418.9" spread="21.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: 30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.1" spread="22.11"/>
                    <measurement group_id="O2" value="427.8" spread="19.67"/>
                    <measurement group_id="O3" value="415.1" spread="7.05"/>
                    <measurement group_id="O4" value="431.6" spread="18.64"/>
                    <measurement group_id="O5" value="423.9" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="419.6" spread="27.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: 1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415.9" spread="15.66"/>
                    <measurement group_id="O2" value="419.5" spread="24.53"/>
                    <measurement group_id="O3" value="435.4" spread="13.98"/>
                    <measurement group_id="O4" value="423.2" spread="15.57"/>
                    <measurement group_id="O5" value="436.7" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="419.9" spread="25.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB: 4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="422.4" spread="13.29"/>
                    <measurement group_id="O2" value="415.5" spread="15.04"/>
                    <measurement group_id="O3" value="439.0" spread="7.14"/>
                    <measurement group_id="O4" value="421.9" spread="28.51"/>
                    <measurement group_id="O5" value="429.3" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="426.4" spread="17.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Number of Participants With Abnormal Respiratory Events</title>
        <description>Number of participants with abnormal respiratory events has been presented</description>
        <time_frame>Up to Day 37</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Number of Participants With Abnormal Respiratory Events</title>
          <description>Number of participants with abnormal respiratory events has been presented</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Forced Expiratory Volume at 1 Minute (FEV1)</title>
        <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.</description>
        <time_frame>Pre dose and 1 hour post dose on Day1</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Forced Expiratory Volume at 1 Minute (FEV1)</title>
          <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.251" spread="0.3125"/>
                    <measurement group_id="O2" value="3.440" spread="0.3121"/>
                    <measurement group_id="O3" value="3.130" spread="0.0707"/>
                    <measurement group_id="O4" value="3.384" spread="0.3051"/>
                    <measurement group_id="O5" value="3.630" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="3.284" spread="0.3488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.184" spread="0.2769"/>
                    <measurement group_id="O2" value="3.374" spread="0.2964"/>
                    <measurement group_id="O3" value="3.110" spread="0.1980"/>
                    <measurement group_id="O4" value="3.306" spread="0.2874"/>
                    <measurement group_id="O5" value="3.380" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="3.190" spread="0.3768"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Percent Oxygen in Blood</title>
        <description>Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries</description>
        <time_frame>Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose</time_frame>
        <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Percent Oxygen in Blood</title>
          <description>Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries</description>
          <population>Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Percentage of oxygen</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" spread="1.4"/>
                    <measurement group_id="O2" value="99.4" spread="0.89"/>
                    <measurement group_id="O3" value="99.0" spread="1.41"/>
                    <measurement group_id="O4" value="97.2" spread="0.84"/>
                    <measurement group_id="O5" value="98.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="97.4" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" spread="1.21"/>
                    <measurement group_id="O2" value="99.0" spread="1.00"/>
                    <measurement group_id="O3" value="99.0" spread="1.41"/>
                    <measurement group_id="O4" value="98.0" spread="1.41"/>
                    <measurement group_id="O5" value="98.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="98.8" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" spread="1.25"/>
                    <measurement group_id="O2" value="98.8" spread="0.84"/>
                    <measurement group_id="O3" value="99.5" spread="0.71"/>
                    <measurement group_id="O4" value="97.8" spread="1.10"/>
                    <measurement group_id="O5" value="98.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="98.4" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" spread="0.9"/>
                    <measurement group_id="O2" value="98.4" spread="1.14"/>
                    <measurement group_id="O3" value="99.5" spread="0.71"/>
                    <measurement group_id="O4" value="98.2" spread="0.84"/>
                    <measurement group_id="O5" value="98.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="98.2" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4" spread="1.27"/>
                    <measurement group_id="O2" value="98.2" spread="1.3"/>
                    <measurement group_id="O3" value="99.0" spread="1.41"/>
                    <measurement group_id="O4" value="98" spread="0.71"/>
                    <measurement group_id="O5" value="99.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="98.2" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" spread="0.82"/>
                    <measurement group_id="O2" value="98.4" spread="0.89"/>
                    <measurement group_id="O3" value="99.5" spread="0.71"/>
                    <measurement group_id="O4" value="97.8" spread="0.84"/>
                    <measurement group_id="O5" value="99.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="98.6" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Absolute Values of Respiration Rate</title>
        <description>Respiration rate was measured in semi-supine position after 5 minutes rest</description>
        <time_frame>Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Absolute Values of Respiration Rate</title>
          <description>Respiration rate was measured in semi-supine position after 5 minutes rest</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre dose, n=7,5,2,5,1,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" spread="1.63"/>
                    <measurement group_id="O2" value="15.8" spread="1.64"/>
                    <measurement group_id="O3" value="18.0" spread="1.41"/>
                    <measurement group_id="O4" value="14.8" spread="1.79"/>
                    <measurement group_id="O5" value="18.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="15.0" spread="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes, n=7,4,2,5,1,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" spread="2.51"/>
                    <measurement group_id="O2" value="17.0" spread="2.16"/>
                    <measurement group_id="O3" value="17.0" spread="2.83"/>
                    <measurement group_id="O4" value="15.2" spread="1.30"/>
                    <measurement group_id="O5" value="14.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="16.8" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes, n=7,5,2,5,1,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" spread="1.86"/>
                    <measurement group_id="O2" value="15.6" spread="1.14"/>
                    <measurement group_id="O3" value="15.5" spread="0.71"/>
                    <measurement group_id="O4" value="15.4" spread="0.55"/>
                    <measurement group_id="O5" value="14.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="16.6" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes, n=7,5,2,5,1,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="1.99"/>
                    <measurement group_id="O2" value="15.6" spread="1.82"/>
                    <measurement group_id="O3" value="14.5" spread="0.71"/>
                    <measurement group_id="O4" value="15.0" spread="1.87"/>
                    <measurement group_id="O5" value="14.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="15.6" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 hour, n=7,5,2,5,1,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" spread="0.79"/>
                    <measurement group_id="O2" value="15.6" spread="1.14"/>
                    <measurement group_id="O3" value="15.0" spread="1.41"/>
                    <measurement group_id="O4" value="13.8" spread="2.05"/>
                    <measurement group_id="O5" value="14.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="15.6" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours, n=7,5,2,5,1,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" spread="1.63"/>
                    <measurement group_id="O2" value="15.4" spread="1.34"/>
                    <measurement group_id="O3" value="17.5" spread="0.71"/>
                    <measurement group_id="O4" value="15.0" spread="2.00"/>
                    <measurement group_id="O5" value="15.0" spread="NA">NA indicates that SD could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="15.6" spread="1.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Plasma Concentration Time Profile of Oxytocin.</title>
        <description>Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Plasma Concentration Time Profile of Oxytocin.</title>
          <description>Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Picograms per milliliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>-1 hour; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O4" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O5" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O6" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-30 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O4" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O5" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O6" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>-15 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O4" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O5" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O6" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 minutes; n=7, 3, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.840" lower_limit="31.71" upper_limit="418.11"/>
                    <measurement group_id="O2" value="1081.270" lower_limit="954.86" upper_limit="1166.49"/>
                    <measurement group_id="O3" value="219.930" lower_limit="36.96" upper_limit="402.90"/>
                    <measurement group_id="O4" value="274.840" lower_limit="47.89" upper_limit="526.82"/>
                    <measurement group_id="O5" value="727.660" lower_limit="727.66" upper_limit="727.66"/>
                    <measurement group_id="O6" value="284.160" lower_limit="157.26" upper_limit="446.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 minutes; n=7, 3, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.710" lower_limit="50.71" upper_limit="664.51"/>
                    <measurement group_id="O2" value="1096.990" lower_limit="910.90" upper_limit="1294.71"/>
                    <measurement group_id="O3" value="496.705" lower_limit="349.05" upper_limit="644.36"/>
                    <measurement group_id="O4" value="345.610" lower_limit="83.23" upper_limit="655.70"/>
                    <measurement group_id="O5" value="1312.740" lower_limit="1312.74" upper_limit="1312.74"/>
                    <measurement group_id="O6" value="539.615" lower_limit="440.78" upper_limit="1060.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes; n=7, 3, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167.250" lower_limit="57.34" upper_limit="551.96"/>
                    <measurement group_id="O2" value="627.240" lower_limit="504.07" upper_limit="812.48"/>
                    <measurement group_id="O3" value="697.740" lower_limit="697.69" upper_limit="697.79"/>
                    <measurement group_id="O4" value="364.740" lower_limit="124.40" upper_limit="567.33"/>
                    <measurement group_id="O5" value="827.940" lower_limit="827.94" upper_limit="827.94"/>
                    <measurement group_id="O6" value="622.175" lower_limit="511.83" upper_limit="1309.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 minutes; n=7, 2, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.500" lower_limit="54.92" upper_limit="471.11"/>
                    <measurement group_id="O2" value="456.100" lower_limit="415.88" upper_limit="496.32"/>
                    <measurement group_id="O3" value="554.120" lower_limit="515.82" upper_limit="592.42"/>
                    <measurement group_id="O4" value="287.980" lower_limit="173.56" upper_limit="507.98"/>
                    <measurement group_id="O5" value="507.620" lower_limit="507.62" upper_limit="507.62"/>
                    <measurement group_id="O6" value="560.665" lower_limit="522.35" upper_limit="899.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.900" lower_limit="62.69" upper_limit="407.67"/>
                    <measurement group_id="O2" value="345.845" lower_limit="205.24" upper_limit="410.44"/>
                    <measurement group_id="O3" value="422.745" lower_limit="395.49" upper_limit="450.00"/>
                    <measurement group_id="O4" value="319.960" lower_limit="189.58" upper_limit="416.07"/>
                    <measurement group_id="O5" value="431.980" lower_limit="431.98" upper_limit="431.98"/>
                    <measurement group_id="O6" value="464.925" lower_limit="417.84" upper_limit="584.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.970" lower_limit="71.72" upper_limit="343.15"/>
                    <measurement group_id="O2" value="197.855" lower_limit="157.07" upper_limit="206.02"/>
                    <measurement group_id="O3" value="228.795" lower_limit="176.11" upper_limit="281.48"/>
                    <measurement group_id="O4" value="250.260" lower_limit="173.25" upper_limit="366.23"/>
                    <measurement group_id="O5" value="266.140" lower_limit="266.14" upper_limit="266.14"/>
                    <measurement group_id="O6" value="234.745" lower_limit="213.78" upper_limit="290.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.510" lower_limit="62.30" upper_limit="278.18"/>
                    <measurement group_id="O2" value="128.060" lower_limit="94.91" upper_limit="139.29"/>
                    <measurement group_id="O3" value="146.675" lower_limit="108.99" upper_limit="184.36"/>
                    <measurement group_id="O4" value="230.840" lower_limit="163.70" upper_limit="290.43"/>
                    <measurement group_id="O5" value="159.500" lower_limit="159.50" upper_limit="159.50"/>
                    <measurement group_id="O6" value="138.780" lower_limit="130.76" upper_limit="176.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.500" lower_limit="57.46" upper_limit="183.49"/>
                    <measurement group_id="O2" value="63.485" lower_limit="50.30" upper_limit="74.87"/>
                    <measurement group_id="O3" value="75.630" lower_limit="53.02" upper_limit="98.24"/>
                    <measurement group_id="O4" value="200.950" lower_limit="130.12" upper_limit="211.65"/>
                    <measurement group_id="O5" value="80.120" lower_limit="80.12" upper_limit="80.12"/>
                    <measurement group_id="O6" value="65.560" lower_limit="60.35" upper_limit="82.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 minutes; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.400" lower_limit="35.50" upper_limit="102.79"/>
                    <measurement group_id="O2" value="29.290" lower_limit="21.05" upper_limit="32.88"/>
                    <measurement group_id="O3" value="34.125" lower_limit="22.53" upper_limit="45.72"/>
                    <measurement group_id="O4" value="133.290" lower_limit="91.63" upper_limit="163.78"/>
                    <measurement group_id="O5" value="39.220" lower_limit="39.22" upper_limit="39.22"/>
                    <measurement group_id="O6" value="30.945" lower_limit="21.41" upper_limit="33.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Hour; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.980" lower_limit="22.90" upper_limit="65.79"/>
                    <measurement group_id="O2" value="15.095" lower_limit="11.32" upper_limit="21.81"/>
                    <measurement group_id="O3" value="22.145" lower_limit="12.03" upper_limit="32.26"/>
                    <measurement group_id="O4" value="84.240" lower_limit="65.27" upper_limit="112.31"/>
                    <measurement group_id="O5" value="21.290" lower_limit="21.29" upper_limit="21.29"/>
                    <measurement group_id="O6" value="15.495" lower_limit="14.69" upper_limit="19.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1.5 Hours; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.180" lower_limit="9.74" upper_limit="28.43"/>
                    <measurement group_id="O2" value="5.580" lower_limit="4.09" upper_limit="1100.01"/>
                    <measurement group_id="O3" value="8.170" lower_limit="4.74" upper_limit="11.60"/>
                    <measurement group_id="O4" value="41.270" lower_limit="30.05" upper_limit="59.89"/>
                    <measurement group_id="O5" value="7.200" lower_limit="7.20" upper_limit="7.20"/>
                    <measurement group_id="O6" value="5.160" lower_limit="4.51" upper_limit="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.250" lower_limit="3.66" upper_limit="15.40"/>
                    <measurement group_id="O2" value="2.885" lower_limit="2.00" upper_limit="19.51"/>
                    <measurement group_id="O3" value="2.960" lower_limit="0.00" upper_limit="5.92"/>
                    <measurement group_id="O4" value="19.770" lower_limit="10.73" upper_limit="23.97"/>
                    <measurement group_id="O5" value="3.500" lower_limit="3.50" upper_limit="3.50"/>
                    <measurement group_id="O6" value="2.460" lower_limit="0.00" upper_limit="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.5 Hours; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.090" lower_limit="0.00" upper_limit="8.86"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="73.60"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O4" value="9.640" lower_limit="5.41" upper_limit="12.03"/>
                    <measurement group_id="O5" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O6" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Hours; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.470" lower_limit="0.00" upper_limit="5.33"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="4.11"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O4" value="5.740" lower_limit="2.64" upper_limit="7.31"/>
                    <measurement group_id="O5" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O6" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Hours; n=7, 4, 2, 5, 1, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.00" upper_limit="2.91"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.00" upper_limit="13.36"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O4" value="2.910" lower_limit="0.00" upper_limit="4.43"/>
                    <measurement group_id="O5" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O6" value="0.000" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Picogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224.25" spread="92.5"/>
                    <measurement group_id="O2" value="838.25" spread="67.2"/>
                    <measurement group_id="O3" value="697.74" spread="0.0"/>
                    <measurement group_id="O4" value="357.38" spread="51.4"/>
                    <measurement group_id="O5" value="1312.74" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="721.68" spread="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>10 minutes post dose</time_frame>
        <population>Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Picogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.98" spread="79.6"/>
                    <measurement group_id="O2" value="293.00" spread="32.1"/>
                    <measurement group_id="O3" value="421.87" spread="9.1"/>
                    <measurement group_id="O4" value="292.95" spread="37.7"/>
                    <measurement group_id="O5" value="431.98" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="407.99" spread="39.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>20 minutes post dose</time_frame>
        <population>Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Picogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131.72" spread="61.1"/>
                    <measurement group_id="O2" value="110.44" spread="26.0"/>
                    <measurement group_id="O3" value="141.75" spread="38.5"/>
                    <measurement group_id="O4" value="231.76" spread="22.2"/>
                    <measurement group_id="O5" value="159.50" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="131.21" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>30 minutes post dose</time_frame>
        <population>Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Picogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.54" spread="49.6"/>
                    <measurement group_id="O2" value="56.70" spread="26.3"/>
                    <measurement group_id="O3" value="72.17" spread="45.8"/>
                    <measurement group_id="O4" value="184.71" spread="20.6"/>
                    <measurement group_id="O5" value="80.12" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="63.02" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08333" lower_limit="0.0500" upper_limit="0.2500"/>
                    <measurement group_id="O2" value="0.04167" lower_limit="0.0333" upper_limit="0.1833"/>
                    <measurement group_id="O3" value="0.0833" lower_limit="0.0833" upper_limit="0.0833"/>
                    <measurement group_id="O4" value="0.0833" lower_limit="0.0500" upper_limit="0.3333"/>
                    <measurement group_id="O5" value="0.05000" lower_limit="0.0500" upper_limit="0.0500"/>
                    <measurement group_id="O6" value="0.08333" lower_limit="0.0833" upper_limit="0.1333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Hour*picogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.58" spread="58.6"/>
                    <measurement group_id="O2" value="161.39" spread="44.1"/>
                    <measurement group_id="O3" value="164.46" spread="15.8"/>
                    <measurement group_id="O4" value="247.42" spread="22.3"/>
                    <measurement group_id="O5" value="208.37" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O6" value="171.21" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only</title>
        <description>Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O3">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only</title>
          <description>Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.</population>
          <units>Liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.93" spread="46.3"/>
                    <measurement group_id="O2" value="50.85" spread="16.1"/>
                    <measurement group_id="O3" value="40.44" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O4" value="49.23" spread="23.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only</title>
        <description>Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O3">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only</title>
          <description>Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.</population>
          <units>Liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.22" spread="56.5"/>
                    <measurement group_id="O2" value="25.50" spread="7.8"/>
                    <measurement group_id="O3" value="20.85" spread="NA">NA indicates that Geometric Coefficient of Variation could not be calculated for a single participant</measurement>
                    <measurement group_id="O4" value="23.47" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (22) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
        <group_list>
          <group group_id="O1">
            <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O2">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O3">
            <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
          </group>
          <group group_id="O4">
            <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
          </group>
          <group group_id="O5">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
          </group>
          <group group_id="O6">
            <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
            <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (22) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5523" lower_limit="0.376" upper_limit="0.882"/>
                    <measurement group_id="O2" value="0.3728" lower_limit="0.341" upper_limit="0.411"/>
                    <measurement group_id="O3" value="0.3525" lower_limit="0.294" upper_limit="0.411"/>
                    <measurement group_id="O4" value="0.6154" lower_limit="0.422" upper_limit="0.721"/>
                    <measurement group_id="O5" value="0.357" lower_limit="0.357" upper_limit="0.357"/>
                    <measurement group_id="O6" value="0.3398" lower_limit="0.260" upper_limit="0.398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Number of Participants With Non-SAEs and SAEs</title>
        <description>An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.</description>
        <time_frame>Up to 15 days</time_frame>
        <population>Safety Population includes participants who received at least one dose of study medication</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Number of Participants With Non-SAEs and SAEs</title>
          <description>An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.</description>
          <population>Safety Population includes participants who received at least one dose of study medication</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.</description>
        <time_frame>30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP: 30 minutes; n=9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.2" spread="10.35"/>
                    <measurement group_id="O2" value="121.5" spread="19.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 2 hours; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.0" spread="16.63"/>
                    <measurement group_id="O2" value="110.0" spread="10.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 30 minutes; n=9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.2" spread="5.31"/>
                    <measurement group_id="O2" value="69.9" spread="11.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 2 hours; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.1" spread="8.48"/>
                    <measurement group_id="O2" value="64.0" spread="9.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Absolute Values of Heart Rate</title>
        <description>Heart rate was measured in semi-supine position after 5 minutes rest</description>
        <time_frame>30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Absolute Values of Heart Rate</title>
          <description>Heart rate was measured in semi-supine position after 5 minutes rest</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes; n= 9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" spread="19.85"/>
                    <measurement group_id="O2" value="86.4" spread="23.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours; n= 9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.0" spread="16.89"/>
                    <measurement group_id="O2" value="83.0" spread="11.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Absolute Values of Respiration Rate</title>
        <description>Respiration rate was measured in semi-supine position after 5 minutes rest</description>
        <time_frame>30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Absolute Values of Respiration Rate</title>
          <description>Respiration rate was measured in semi-supine position after 5 minutes rest</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="2.55"/>
                    <measurement group_id="O2" value="14.6" spread="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" spread="2.06"/>
                    <measurement group_id="O2" value="14.1" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Absolute Values of Temperature</title>
        <description>Body temperature was measured in semi-supine position after 5 minutes rest</description>
        <time_frame>30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Absolute Values of Temperature</title>
          <description>Body temperature was measured in semi-supine position after 5 minutes rest</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.29" spread="0.699"/>
                    <measurement group_id="O2" value="36.69" spread="0.135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.03" spread="0.581"/>
                    <measurement group_id="O2" value="36.90" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in SBP and DBP</title>
        <description>SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in SBP and DBP</title>
          <description>SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP: 30 minutes; n= 9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="8.39"/>
                    <measurement group_id="O2" value="11.4" spread="17.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: 2 hours; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="13.27"/>
                    <measurement group_id="O2" value="-0.9" spread="13.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 30 minutes; n= 9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="11.14"/>
                    <measurement group_id="O2" value="-0.1" spread="13.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: 2 hours; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="10.43"/>
                    <measurement group_id="O2" value="-6.0" spread="11.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Heart Rate</title>
        <description>Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Heart Rate</title>
          <description>Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes; n= 9, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="16.41"/>
                    <measurement group_id="O2" value="4.8" spread="22.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours; n=9, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="10.39"/>
                    <measurement group_id="O2" value="1.9" spread="9.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Respiration Rate</title>
        <description>Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Respiration Rate</title>
          <description>Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="2.12"/>
                    <measurement group_id="O2" value="-0.3" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="2.24"/>
                    <measurement group_id="O2" value="-0.7" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Body Temperature</title>
        <description>Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose</time_frame>
        <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Body Temperature</title>
          <description>Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at specified data points were analyzed.</population>
          <units>Degrees Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.60" spread="0.740"/>
                    <measurement group_id="O2" value="-0.01" spread="0.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.623"/>
                    <measurement group_id="O2" value="0.20" spread="0.277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin</title>
        <description>Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>400 mcg Oxytocin IH</title>
            <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labo (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>17 mcg Oxytocin IM</title>
            <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin</title>
          <description>Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Hour*picogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA indicates that data could not be calculated as all values at specified time points (up to 3 hours post-dose) were below the limit of quantification.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">NA indicates that data could not be calculated as all values at specified time points (up to 3 hours post-dose) were below the limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Day 15 for Part 1 and up to Day 37 for Part 2.</time_frame>
      <desc>Non-SAEs and SAEs are reported for Safety Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>400 mcg Oxytocin IH</title>
          <description>Participants with uncomplicated pregnancy received 400 micrograms (mcg) IH oxytocin during third stage of labor (within 5 minutes of birth) via ROTAHALER dry powder inhaler (DPI). Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
        </group>
        <group group_id="E2">
          <title>17 mcg Oxytocin IM</title>
          <description>Participants with uncomplicated pregnancy received 17 mcg IM oxytocin injection during third stage of labor (within 5 minutes of birth) in the anterior shoulder. Participants were followed up in-person or via telephone within approximately 24 hours post dose and once between 7 days to 14 days.</description>
        </group>
        <group group_id="E3">
          <title>Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
          <description>Healthy participants of childbearing potential receiving oral contraceptive along with 400 mcg oxytocin IH</description>
        </group>
        <group group_id="E4">
          <title>Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
          <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
        </group>
        <group group_id="E5">
          <title>Combined Oral Contraceptives+ 8.5 mcg Oxytocin IV Infusion</title>
          <description>Healthy participants of childbearing potential receiving oral contraceptive along with 8.5 mcg oxytocin IV.</description>
        </group>
        <group group_id="E6">
          <title>Non-Combined Oral Contraceptives+400 mcg Oxytocin IH</title>
          <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 400 mcg oxytocin IH.</description>
        </group>
        <group group_id="E7">
          <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Bolus</title>
          <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV bolus. When the duration of IV oxytocin administered was less than or equal to 2 minutes then the IV dose administered was classified as an IV Bolus.</description>
        </group>
        <group group_id="E8">
          <title>Non-Combined Oral Contraceptive+ 8.5 mcg Oxytocin IV Infusion</title>
          <description>Healthy participants of childbearing potential using a non-hormonal form of contraception along with 8.5 mcg oxytocin IV.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Postpartum haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nipple infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Perineal injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="5" subjects_affected="4" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Postpartum haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999100
org study id: 205920
secondary id: 2016-002672-27
nct id: NCT02999100
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The study will evaluate a stable, dry-powder formulation of oxytocin, with the goal of
      reducing post-partum hemorrhage morbidity and mortality in resource poor settings. This study
      is being conducted to further assess safety and tolerability of inhaled oxytocin, and to
      characterize the drug levels of inhaled (IH) oxytocin when compared to oxytocin administered
      as standard of care. Two groups of subjects will be enrolled. Group 1 will enroll pregnant
      women, who will be randomized to receive either IH or intramuscular (IM) oxytocin as active
      management of the third stage of labour (after the baby is born). Group 2 will enroll
      non-pregnant women of childbearing potential, who will receive IH oxytocin and intravenous
      (IV) oxytocin in a cross over design over two dosing sessions This group will evaluate the
      safety and tolerability of IH and IV oxytocin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part 1: Plasma Concentration Time Profile of Oxytocin
time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
description: Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin
time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
description: Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin
time frame: 10 minutes post dose Day 1
description: Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin
time frame: 20 minutes post dose Day 1
description: Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin
time frame: 30 minutes post dose Day 1
description: Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin
time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1
description: Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin
time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1
description: Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Terminal Phase Half-life (t1/2) of Oxytocin
time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1
description: Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.
measure: Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
time frame: Up to 37 days
description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.
measure: Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
description: Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
measure: Part 2: Change From Baseline in SBP and DBP
time frame: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
description: SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
measure: Part 2: Change From Baseline in Heart Rate
time frame: Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
description: Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
measure: Part 2: Absolute Values of Heart Rate
time frame: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose
description: Heart rate was measured in semi-supine position after 5 minutes rest
measure: Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval
time frame: Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose
description: Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.
measure: Part 2: Number of Participants With Abnormal Respiratory Events
time frame: Up to Day 37
description: Number of participants with abnormal respiratory events has been presented
measure: Part 2: Forced Expiratory Volume at 1 Minute (FEV1)
time frame: Pre dose and 1 hour post dose on Day1
description: FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.
measure: Part 2: Percent Oxygen in Blood
time frame: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose
description: Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries
measure: Part 2: Absolute Values of Respiration Rate
time frame: Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose
description: Respiration rate was measured in semi-supine position after 5 minutes rest
measure: Part 2: Plasma Concentration Time Profile of Oxytocin.
time frame: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin
time frame: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin
time frame: 10 minutes post dose
description: Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin
time frame: 20 minutes post dose
description: Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin
time frame: 30 minutes post dose
description: Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin
time frame: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin
time frame: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only
time frame: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only
time frame: -1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin
time frame: -1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose
description: Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Part 1: Number of Participants With Non-SAEs and SAEs
time frame: Up to 15 days
description: An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.
measure: Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: 30 minutes and 2 hours post dose
description: Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.
measure: Part 1: Absolute Values of Heart Rate
time frame: 30 minutes and 2 hours post dose
description: Heart rate was measured in semi-supine position after 5 minutes rest
measure: Part 1: Absolute Values of Respiration Rate
time frame: 30 minutes and 2 hours post dose
description: Respiration rate was measured in semi-supine position after 5 minutes rest
measure: Part 1: Absolute Values of Temperature
time frame: 30 minutes and 2 hours post dose
description: Body temperature was measured in semi-supine position after 5 minutes rest
measure: Part 1: Change From Baseline in SBP and DBP
time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
description: SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
measure: Part 1: Change From Baseline in Heart Rate
time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
description: Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
measure: Part 1: Change From Baseline in Respiration Rate
time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
description: Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
measure: Part 1: Change From Baseline in Body Temperature
time frame: Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose
description: Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
measure: Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin
time frame: Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1
description: Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.
arm group label: Group 1 -IH oxytocin
arm group type: Experimental
description: Women with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 400 micrograms (mcg) IH oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days
arm group label: Group 1 -IM oxytocin
arm group type: Experimental
description: Women with an uncomplicated pregnancy in third stage of labour will be enrolled in the arm. Subjects will receive 10 I.U. IM oxytocin. Subjects will be followed up in-person or via telephone within approximately 24 hr post dose and once between 7 days to 14 days
arm group label: Group 2 (IH and IV oxytocin)
arm group type: Experimental
description: Group 2 will enrol healthy, non-pregnant, non-lactating female subjects of childbearing potential, and each subject will participate in 2 dosing sessions. Group 2 will be divided into two cohorts: Cohort A will enrol women on a combined oral contraceptive, and Cohort B will enrol women who are not using a hormonal form of contraceptive. Group 2 subjects will randomized to receive IH oxytocin, and IV oxytocin in a cross fashion. Subjects will be followed up in-person once between 7 days to 21 days
intervention type: Drug
intervention name: IH Oxytocin
description: Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).
arm group label: Group 1 -IH oxytocin
arm group label: Group 2 (IH and IV oxytocin)
intervention type: Drug
intervention name: IM Oxytocin
description: Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration
arm group label: Group 1 -IM oxytocin
intervention type: Drug
intervention name: IV Oxytocin
description: Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.
arm group label: Group 2 (IH and IV oxytocin)
intervention type: Device
intervention name: ROTAHALER
description: ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin
arm group label: Group 1 -IH oxytocin
arm group label: Group 2 (IH and IV oxytocin)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
country: Australia
country: United Kingdom
responsible party type: Sponsor
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
mesh term: Oxytocin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 