A Phase 4 interventional study of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20mcg/Norethindrone 1mg in Postpartum Depressive Mood and Postpartum Sexual Function, sponsored by The Jones Institute. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-07.
Sponsored by The Jones Institute · Phase 4, Interventional, and Prevention
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's planned enrollment of 33 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →This is the only study on the registry with The Jones Institute as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria (Medication groups):
Exclusion Criteria (Control group):
21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum
Drug: Ethinyl Estradiol 35mcg/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
Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy).
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
Time to First Coitus
Time frame: Time to first coitus during postpartum period
Urine Pregnancy Test
Time frame: Week 6-7 Postpartum
This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.