Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales

August 4, 2014 updated by: The Jones Institute
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-45 year old women who desire contraception postpartum for at least 6 weeks.
  • 18-45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group.

Exclusion Criteria (Medication groups):

  • Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population).
  • Delivery by cesarean section.
  • Previous history of depression, mood disorders, or psychiatric disorders.
  • Any condition (history or presence of) which contraindicates the use of combination OCs, including:
  • Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders.
  • Pulmonary Embolism.
  • Cerebrovascular or coronary artery disease or myocardial infarction.
  • Diabetes mellitus.
  • Migraine headaches with focal, neurological symptoms.
  • Chronic renal disease.
  • Uncontrolled or untreated hypertension.
  • Cholestatic jaundice.
  • Known or suspected carcinoma of the breast, endometrial carcinoma, or known or suspected estrogen-dependent neoplasia.
  • Impaired liver function or disease, hepatic adenomas or carcinomas.
  • Known hypersensitivity to estrogens and/or progestins.
  • History of thyroid disorders.
  • Recent alcohol or drug use.
  • Smoking and age ≥35 or smokers who will become 35 years of age during the study.
  • Known history of noncompliance with taking medication.

Exclusion Criteria (Control group):

  • Previous history of depression, mood disorders, or psychiatric disorders.
  • Recent alcohol or drug use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ethinyl Estradiol 35mcg/Noethindrone 1mg
21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Drug: Ethinyl Estradiol 35mcg/Norethindrone 1mg
Experimental: Ethinyl Estradiol 20mcg/Norethindrone 1mg
21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Drug: Ethinyl Estradiol 20mcg/Norethindrone 1mg
No Intervention: No hormonal contraception
Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
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
Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum
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
Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to First Coitus
Time Frame: Time to first coitus during postpartum period
Time to first coitus during postpartum period
Urine Pregnancy Test
Time Frame: Week 6-7 Postpartum
Week 6-7 Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Jones Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-06-FB-0118-HOSP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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