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Hormone Therapy

Oral Contraceptives for Postpartum Depression

Phase 4

Waitlist Available

Research Sponsored by The Jones Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (0-1 days postpartum), week 3 postpartum, week 6-7 postpartum

Awards & highlights

Study Summary

This trial will compare the effect of two different doses of a common birth control pill on postpartum depression and sexual function.

Who is the study for?

This trial is for women aged 18-45 who recently gave birth and want contraception, or choose not to use it (control group). They should desire this for at least 6 weeks postpartum. The study aims to understand how two doses of Ethinyl Estradiol/Norethindrone affect postpartum depression and sexual functioning.Check my eligibility

What is being tested?

The study compares the effects of two oral contraceptives with different Ethinyl Estradiol doses on postpartum depression and sexual health. Women will be randomly assigned to receive either a higher dose, a lower dose, or no hormonal contraceptive, and their mood and sexual function will be tracked over several weeks.See study design

What are the potential side effects?

Potential side effects from the oral contraceptives may include mood changes, headache, nausea, breast tenderness, weight gain, menstrual changes or spotting between periods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time to first coitus during postpartum period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time to first coitus during postpartum period

This trial's timeline: 3 weeks for screening, Varies for treatment, and time to first coitus during postpartum period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum

Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum

Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum

Secondary outcome measures

Time to First Coitus

Urine Pregnancy Test

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Ethinyl Estradiol 35mcg/Noethindrone 1mgExperimental Treatment1 Intervention

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

Group II: Ethinyl Estradiol 20mcg/Norethindrone 1mgExperimental Treatment1 Intervention

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

Group III: No hormonal contraceptionActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Jones InstituteLead Sponsor

Media Library

Ethinyl Estradiol 20mcg/Norethindrone 1mg (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02210702 — Phase 4

Postpartum Depression Clinical Trial 2023: Ethinyl Estradiol 20mcg/Norethindrone 1mg Highlights & Side Effects. Trial Name: NCT02210702 — Phase 4

Ethinyl Estradiol 20mcg/Norethindrone 1mg (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02210702 — Phase 4

Postpartum Depression Research Study Groups: Ethinyl Estradiol 35mcg/Noethindrone 1mg, Ethinyl Estradiol 20mcg/Norethindrone 1mg, No hormonal contraception

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in this investigation?

"This research project is no longer recruiting. It was first published on July 1st 2014 and its last update came out August 4th 2014. For those still wishing to participate in a clinical trial, there are currently 75 trials for depression, postpartum, and 20 studies related to Ethinyl Estradiol 35mcg/Norethindrone 1mg actively looking for volunteers."

Answered by AI

Are there any open slots still available for participants in this trial?

"Unfortunately, recruitment for this trial has been closed. Initially posted on July 1st 2014 and last updated August 4th of the same year, applicants are no longer being accepted. If you're interested in other studies, 75 clinical trials recruiting participants with depression or postpartum issues can be found as well as 20 seeking patients taking Ethinyl Estradiol 35mcg/Norethindrone 1mg."

Answered by AI

May I join this research endeavor?

"To be considered for this research project, potential participants must report symptoms of depression and have given birth in the past. The age range accepted is from 18 to 45 years old, with 33 enrollees being admitted into the study."

Answered by AI

Has the Food and Drug Administration endorsed Ethinyl Estradiol 35mcg/Norethindrone 1mg?

"The safety of Ethinyl Estradiol 35mcg/Norethindrone 1mg was rated at a 3, as it is already approved due to its successful completion of Phase 4 testing."

Answered by AI

Is eligibility for this trial restricted to individuals over 65 years of age?

"Potential participants of this research must meet the criteria of aged 18 to 45. There are 22 studies exclusively for those under 18 and 39 specifically designed for individuals over 65 years old."

Answered by AI

To what extent has the combination of Ethinyl Estradiol 35mcg/Norethindrone 1mg been investigated in prior research?

"Currently, Ethinyl Estradiol 35mcg/Norethindrone 1mg is the subject of 20 active medical investigations with 8 reaching Phase 3. Most studies are hosted in Savannah, Georgia yet there exist 632 total clinical locations around the country."

Answered by AI

What is the common purpose of using Ethinyl Estradiol 35mcg/Norethindrone 1mg?

"Ethinyl Estradiol 35mcg/Norethindrone 1mg is a popular medication for premenstrual dysphoric disorder, contraception needs, female castration requirements and acne vulgaris."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2014. "Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02210702.

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