<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/NCT01723579</url>
  </required_header>
  <id_info>
    <org_study_id>P07057</org_study_id>
    <secondary_id>MK-8175A-017</secondary_id>
    <nct_id>NCT01723579</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017)</brief_title>
  <official_title>An Open-label, Multi-center Trial to Evaluate the Contraceptive Efficacy, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) in Indian Women. Protocol MK-8175A-017-00</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organon and Co</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Organon and Co</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the efficacy and safety of the monophasic&#xD;
&#xD;
      combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in&#xD;
&#xD;
      healthy fertile Indian women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of In-treatment Pregnancies</measure>
    <time_frame>Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing an Adverse Event (AE) or Serious AE</measure>
    <time_frame>&quot;From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>NOMAC-E2 2.5 mg/1.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nomegestrol acetate (NOMAC)</intervention_name>
    <description>Oral tablet with daily release of 2.5 mg</description>
    <arm_group_label>NOMAC-E2 2.5 mg/1.5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol (E2)</intervention_name>
    <description>Daily release of 1.5 mg</description>
    <arm_group_label>NOMAC-E2 2.5 mg/1.5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sexually active and at risk for pregnancy&#xD;
&#xD;
          -  Of Indian descent, born in India, never emigrated out of India, with Indian&#xD;
&#xD;
        home address&#xD;
&#xD;
          -  Body mass index (BMI) ≥17 and ≤35 kg/m^2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or history of venous or arterial thrombotic/thromboembolic events&#xD;
&#xD;
        or cerebrovascular accident&#xD;
&#xD;
          -  Presence or history of prodromi of a thrombosis&#xD;
&#xD;
          -  History of migraine with focal neurological symptoms&#xD;
&#xD;
          -  Diabetes mellitus with vascular involvement&#xD;
&#xD;
          -  Presence of a severe or multiple risk factor(s) for venous or arterial&#xD;
&#xD;
        thrombosis&#xD;
&#xD;
          -  Severe hypertension&#xD;
&#xD;
          -  Severe dyslipoproteinemia&#xD;
&#xD;
          -  Presence or history of pancreatitis associated with severe&#xD;
&#xD;
        hypertriglyceridemia&#xD;
&#xD;
          -  Presence or history of severe hepatic disease&#xD;
&#xD;
          -  Undiagnosed vaginal bleeding&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  Currently breastfeeding or breastfeeding within 2 months of starting&#xD;
&#xD;
        trial medication&#xD;
&#xD;
        - Investigational drug use or participation in another clinical trial within&#xD;
&#xD;
        2 months of signing Informed Consent Form for current trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01723579
org study id: P07057
secondary id: MK-8175A-017
nct id: NCT01723579
lead sponsor: 
has dmc: No
This study will investigate the efficacy and safety of the monophasic

      combined oral contraceptive (COC) containing 2.5 mg NOMAC and 1.5 mg E2 in

      healthy fertile Indian women.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of In-treatment Pregnancies
time frame: Day 1 of Treatment Cycle 1 Through Day 28 of Treatment Cycle 13, plus up to 2 additional days (Study Days 1-366)
measure: Number of Participants Experiencing an Adverse Event (AE) or Serious AE
time frame: "From Visit 1 up to 30 days after the last dose of study medication (up to Study Day 394).
arm group label: NOMAC-E2 2.5 mg/1.5 mg
arm group type: Experimental
description: Participants will receive combined oral contraceptive NOMAC-E2 2.5 mg/1.5 mg tablet for 13 consecutive 28-day cycles. Each 28-day cycle with consist of 24 active tablets and 4 placebo tablets taken at approximately the same time each day.
intervention type: Drug
intervention name: Nomegestrol acetate (NOMAC)
description: Oral tablet with daily release of 2.5 mg
arm group label: NOMAC-E2 2.5 mg/1.5 mg
intervention type: Drug
intervention name: Estradiol (E2)
description: Daily release of 1.5 mg
arm group label: NOMAC-E2 2.5 mg/1.5 mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Estradiol