drugset / Trial / NCT02210702

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

NCT02210702

Phase 4 Unknown 33 enrolled The Jones Institute
RandomizedSingle-groupDouble-blindPrevention

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.

Timeline

Start
2014-07
Primary completion
2015-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject ethinyl estradiol Small molecule 20 ug Oral
Subject ethinyl estradiol Small molecule 35 ug Oral
Background Norethindrone Unknown 1 mg Oral

Indications