<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/NCT02210702</url>
  </required_header>
  <id_info>
    <org_study_id>14-06-FB-0118-HOSP</org_study_id>
    <nct_id>NCT02210702</nct_id>
  </id_info>
  <brief_title>Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales</brief_title>
  <official_title>Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Jones Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Jones Institute</source>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, controlled cohort study. This study will look at the&#xD;
      effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20&#xD;
      mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when&#xD;
      compared to a control group using no hormonal contraception. Depressive symptoms and sexual&#xD;
      function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona&#xD;
      Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W).&#xD;
      Participants will begin taking the medication at Week 3 postpartum, and these outcomes will&#xD;
      be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators&#xD;
      hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and&#xD;
      BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and&#xD;
      increase in sexual function in both of the oral contraceptive groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum</measure>
    <time_frame>Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum</measure>
    <time_frame>Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum</measure>
    <time_frame>Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to First Coitus</measure>
    <time_frame>Time to first coitus during postpartum period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Pregnancy Test</measure>
    <time_frame>Week 6-7 Postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Postpartum Depressive Mood</condition>
  <condition>Postpartum Sexual Function</condition>
  <arm_group>
    <arm_group_label>Ethinyl Estradiol 35mcg/Noethindrone 1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ethinyl Estradiol 20mcg/Norethindrone 1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No hormonal contraception</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethinyl Estradiol 35mcg/Norethindrone 1mg</intervention_name>
    <arm_group_label>Ethinyl Estradiol 35mcg/Noethindrone 1mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethinyl Estradiol 20mcg/Norethindrone 1mg</intervention_name>
    <arm_group_label>Ethinyl Estradiol 20mcg/Norethindrone 1mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 year old women who desire contraception postpartum for at least 6 weeks.&#xD;
&#xD;
          -  18-45 year old women who choose not to use oral contraceptive medication postpartum&#xD;
             for at least 6 weeks for the control group.&#xD;
&#xD;
        Exclusion Criteria (Medication groups):&#xD;
&#xD;
          -  Breastfeeding (although this may limit participant enrollment, combined oral&#xD;
             contraceptives are contraindicated in this population).&#xD;
&#xD;
          -  Delivery by cesarean section.&#xD;
&#xD;
          -  Previous history of depression, mood disorders, or psychiatric disorders.&#xD;
&#xD;
          -  Any condition (history or presence of) which contraindicates the use of combination&#xD;
             OCs, including:&#xD;
&#xD;
          -  Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders,&#xD;
             deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders.&#xD;
&#xD;
          -  Pulmonary Embolism.&#xD;
&#xD;
          -  Cerebrovascular or coronary artery disease or myocardial infarction.&#xD;
&#xD;
          -  Diabetes mellitus.&#xD;
&#xD;
          -  Migraine headaches with focal, neurological symptoms.&#xD;
&#xD;
          -  Chronic renal disease.&#xD;
&#xD;
          -  Uncontrolled or untreated hypertension.&#xD;
&#xD;
          -  Cholestatic jaundice.&#xD;
&#xD;
          -  Known or suspected carcinoma of the breast, endometrial carcinoma, or known or&#xD;
             suspected estrogen-dependent neoplasia.&#xD;
&#xD;
          -  Impaired liver function or disease, hepatic adenomas or carcinomas.&#xD;
&#xD;
          -  Known hypersensitivity to estrogens and/or progestins.&#xD;
&#xD;
          -  History of thyroid disorders.&#xD;
&#xD;
          -  Recent alcohol or drug use.&#xD;
&#xD;
          -  Smoking and age ≥35 or smokers who will become 35 years of age during the study.&#xD;
&#xD;
          -  Known history of noncompliance with taking medication.&#xD;
&#xD;
        Exclusion Criteria (Control group):&#xD;
&#xD;
          -  Previous history of depression, mood disorders, or psychiatric disorders.&#xD;
&#xD;
          -  Recent alcohol or drug use.&#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>
  <overall_contact>
    <last_name>Kelly McDaniel, MS</last_name>
    <email>mcdanik@evms.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Norethindrone</mesh_term>
    <mesh_term>Norethindrone Acetate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</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/NCT02210702
org study id: 14-06-FB-0118-HOSP
nct id: NCT02210702
lead sponsor: 
This is a prospective, randomized, controlled cohort study. This study will look at the
      effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20
      mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when
      compared to a control group using no hormonal contraception. Depressive symptoms and sexual
      function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona
      Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W).
      Participants will begin taking the medication at Week 3 postpartum, and these outcomes will
      be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators
      hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and
      BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and
      increase in sexual function in both of the oral contraceptive groups.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum
time frame: Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
measure: Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum
time frame: Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
measure: Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum
time frame: Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
measure: Time to First Coitus
time frame: Time to first coitus during postpartum period
measure: Urine Pregnancy Test
time frame: Week 6-7 Postpartum
arm group label: Ethinyl Estradiol 35mcg/Noethindrone 1mg
arm group type: Experimental
description: 21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
arm group label: Ethinyl Estradiol 20mcg/Norethindrone 1mg
arm group type: Experimental
description: 21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
arm group label: No hormonal contraception
arm group type: No Intervention
description: Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).
intervention type: Drug
intervention name: Ethinyl Estradiol 35mcg/Norethindrone 1mg
arm group label: Ethinyl Estradiol 35mcg/Noethindrone 1mg
intervention type: Drug
intervention name: Ethinyl Estradiol 20mcg/Norethindrone 1mg
arm group label: Ethinyl Estradiol 20mcg/Norethindrone 1mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly McDaniel, MS
email: mcdanik@evms.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Ethinyl Estradiol
mesh term: Norethindrone
mesh term: Norethindrone Acetate
mesh term: Estradiol
mesh term: Polyestradiol phosphate