Postmenopausal, topical vaginal estrogen cream for Pelvic Floor Disorders

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Pelvic Floor Disorders+2 More
Postmenopausal, topical vaginal estrogen cream - Drug
Eligibility
18+
Female
What conditions do you have?
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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.

Eligible Conditions
  • Pelvic Floor Disorders

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1-month perioperative study

1-month perioperative study
Histologic assessment of excised tissue
Vaginal epithelial thickness

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Pre-menopausal, no topical vaginal cream
1 of 3
Postmenopausal, topical vaginal cream
1 of 3
Postmenopausal, topical placebo cream
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

10 Total Participants · 3 Treatment Groups

Primary Treatment: Postmenopausal, topical vaginal estrogen cream · Has Placebo Group · Phase 4

Postmenopausal, topical vaginal cream
Drug
Experimental Group · 1 Intervention: Postmenopausal, topical vaginal estrogen cream · Intervention Types: Drug
Pre-menopausal, no topical vaginal creamNoIntervention Group · 1 Intervention: Pre-menopausal, no topical vaginal cream · Intervention Types:
Postmenopausal, topical placebo cream
Drug
PlaceboComparator Group · 1 Intervention: Placebo Comparator: Postmenopausal, topical placebo cream · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1-month perioperative study

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
221 Previous Clinical Trials
55,329 Total Patients Enrolled
Kathleen Vincent, MDPrincipal InvestigatorUTMB Galveston

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: October 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.