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Estrogen

Vaginal Estrogen Cream for Postpartum Recovery

Phase 4

Recruiting

Led By Hannah L Chapman, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Must be able to self apply vaginal cream

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months postpartum

Awards & highlights

Study Summary

This trial will test whether intra-vaginal estrogen therapy improves sexual function and incontinence symptom distress and impact for postpartum women after sustaining an obstetric anal sphincter injury.

Who is the study for?

This trial is for women aged 18 or older who have experienced severe tears during childbirth (3rd or 4th degree lacerations) and can apply vaginal cream themselves. It's not suitable for those with a history of blood clots, stroke, hormone-sensitive breast cancer, tobacco use, allergies to estradiol cream or its ingredients, or if they have an infection at the site of injury.Check my eligibility

What is being tested?

The study tests whether applying a topical vaginal estrogen cream (Estradiol 0.01%) after childbirth helps with recovery from obstetric anal sphincter injuries compared to a placebo cream. The focus is on improving sexual function and reducing distress from urinary and bowel incontinence.See study design

What are the potential side effects?

Potential side effects may include local irritation where the cream is applied, hormonal changes that could affect mood or periods, and possibly increased risk of blood clots although this risk is generally lower with topical application than other forms of estrogen therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can apply vaginal cream by myself.

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I am 18 years old or older.

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I have experienced severe tearing during childbirth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

sexual dysfunction symptom severity

Secondary outcome measures

Anal incontinence

Urinary incontinence

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Topical vaginal estrogen groupActive Control1 Intervention

Estradiol vaginal cream 0.01% 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g estradiol vaginal cream 0.01% will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy

Group II: Placebo groupPlacebo Group1 Intervention

Placebo cream, 1g will be administered vaginally, initiated at 2 weeks postpartum and continued until 6 months postpartum. Beginning at 2 weeks postpartum, 1g of placebo cream will be administered by participants nightly for 2 weeks then twice weekly to complete 6 months therapy.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,586 Previous Clinical Trials

2,280,182 Total Patients Enrolled

Hannah L Chapman, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Estradiol 0.01% Vag Cream (Estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT05317364 — Phase 4

Bowel Incontinence Research Study Groups: Topical vaginal estrogen group, Placebo group

Bowel Incontinence Clinical Trial 2023: Estradiol 0.01% Vag Cream Highlights & Side Effects. Trial Name: NCT05317364 — Phase 4

Estradiol 0.01% Vag Cream (Estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317364 — Phase 4

Frequently Asked Questions

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

Is this a closed or open clinical trial?

"Yes, this study is still looking for patients. The listing on clinicaltrials.gov says that the trial was posted on 7/14/2022 and last updated on 7/21/2022. They are hoping to find 50 people total to participate at 1 site."

Answered by AI

What is the most current FDA rating for products in the Topical vaginal estrogen group?

"Topical vaginal estrogen group scored a 3 for safety because it is a Phase 4 trial, meaning that this medication has been approved."

Answered by AI

How many total participants are in this clinical trial?

"That is correct. According to the clinicaltrials.gov website, this trial was posted on 7/14/2022 and is presently looking for 50 participants across 1 site."

Answered by AI