Recruiting

Ethinyl Estradiol

Sponsor:

The Jones Institute

Code:

NCT02210702

Conditions

Postpartum Depressive Mood

Postpartum Sexual Function

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Ethinyl Estradiol 35mcg/Norethindrone 1mg

Ethinyl Estradiol 20mcg/Norethindrone 1mg

Study Details

Brief summary:

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.

Conditions

Postpartum Depressive Mood

Postpartum Sexual Function

Study ID

NCT02210702

Start date

Jul, 2014

Status verified date

Aug, 2014

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ethinyl Estradiol 35mcg/Noethindrone 1mg

21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum

experimental: Ethinyl Estradiol 20mcg/Norethindrone 1mg

21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum

no intervention: No hormonal contraception

Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).

Interventions

Ethinyl Estradiol 35mcg/Norethindrone 1mg

Ethinyl Estradiol 20mcg/Norethindrone 1mg

Primary outcome 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Kelly McDaniel, MS

mcdanik@evms.edu

Locations

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

The Jones Institute

Last update posted

Aug 7, 2014

Last verified

Aug, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Jones Institute on 2014-08-07.