Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02210702
Status:
UNKNOWN
Last Update Posted:
2014-08-07
First Post:
2014-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Sponsor:
The Jones Institute
Organization:
Study Overview
Official Title:
Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: