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Estrogen Cream for Pelvic Organ Prolapse

Phase 4
Waitlist Available
Led By Kathleen Vincent, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals electing surgery to treat their POP
21 to 70 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-month perioperative study
Awards & highlights

Study Summary

This trial is testing if there are differences in muscle and connective tissue between postmenopausal women and women of reproductive age with pelvic floor dysfunction, in order to develop better targeted treatments.

Who is the study for?
This trial is for women aged 21-70 with Stage II or greater pelvic organ prolapse who are planning surgery. It's open to those willing to follow the study procedures and provide consent. Excluded are those with psychiatric conditions, increased medical risks, prior hysterectomy or POP surgery, allergies to protocol agents, recent hormone therapy use, pregnancy/lactation, or connective tissue disease.Check my eligibility
What is being tested?
The study tests how topical vaginal estrogen cream affects blood flow and tissue in postmenopausal women with pelvic floor dysfunction compared to a placebo cream. The goal is to understand muscle and connective tissue changes for developing noninvasive treatments.See study design
What are the potential side effects?
Potential side effects of the topical estrogen cream may include local irritation or redness at the application site, hormonal changes like hot flashes or mood swings, and possibly an increase in uterine lining thickness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am choosing surgery to treat my pelvic organ prolapse.
Select...
I am between 21 and 70 years old.
Select...
My pelvic organ prolapse is at stage II or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-month perioperative study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month perioperative study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaginal epithelial thickness
Secondary outcome measures
Histologic assessment of excised tissue

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Postmenopausal, topical vaginal creamExperimental Treatment1 Intervention
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
Group II: Pre-menopausal, no topical vaginal creamActive Control1 Intervention
Pre-menopausal, no topical vaginal cream. These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
Group III: Postmenopausal, topical placebo creamPlacebo Group1 Intervention
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to placebo.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
56,588 Total Patients Enrolled
Kathleen Vincent, MDPrincipal InvestigatorUTMB Galveston

Media Library

Placebo Comparator: Postmenopausal, topical placebo cream Clinical Trial Eligibility Overview. Trial Name: NCT01886794 — Phase 4
Pelvic Floor Dysfunction Research Study Groups: Postmenopausal, topical vaginal cream, Postmenopausal, topical placebo cream, Pre-menopausal, no topical vaginal cream
Pelvic Floor Dysfunction Clinical Trial 2023: Placebo Comparator: Postmenopausal, topical placebo cream Highlights & Side Effects. Trial Name: NCT01886794 — Phase 4
Placebo Comparator: Postmenopausal, topical placebo cream 2023 Treatment Timeline for Medical Study. Trial Name: NCT01886794 — Phase 4

Frequently Asked Questions

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

Is the Postmenopausal, topical vaginal estrogen cream sanctioned by the FDA?

"Evidence from a Phase 4 trial has led our team to conclude that postmenopausal, topical vaginal estrogen cream is safe and thus merits a score of 3."

Answered by AI

Does the criteria for this medical experiment specify a maximum age limit?

"In accordance with the criteria for participation, individuals must be over 21 years of age and under 70 in order to qualify."

Answered by AI

Am I eligible to partake in this medical study?

"This clinical study is looking for 10 individuals between the age of 21 and 70 who suffer from pelvic floor disorders. To be eligible, participants must meet these additional requirements: Stage II or higher POP; elect surgery to treat their condition; comply with trial tasks; provide written consent."

Answered by AI

Could individuals with the necessary criteria currently partake in this research?

"As detailed on clinicaltrials.gov, this research project is not currently recruiting participants; though it was originally uploaded in June 2013 and last altered at the end of October 2021. However, there are 152 other studies actively looking for patients to participate."

Answered by AI

What is the current enrollment capacity for this clinical trial?

"At present, this research trial is not searching for new members. It was initially posted on June 1st 2013 and last edited 29th October 2021. For those still interested in taking part in medical studies related to pelvic floor disorders there are currently 96 trials actively recruiting participants while 56 clinical trials require Postmenopausal individuals that plan on using topical vaginal estrogen cream as treatment."

Answered by AI

What clinical conditions can Postmenopausal, topical vaginal estrogen cream be prescribed to address?

"Postmenopausal women are often treated with a topical estrogen cream to address organic conditions. This medical treatment can also be utilized for advanced androgen-dependent prostate cancer, amenorrhea in the preceding 6 months, or hypoestrogenism."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
2013. "Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01886794.
~1 spots leftby Apr 2025
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