Estradiol vaginal cream for Urinary Incontinence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of South Florida, Tampa, FL
Urinary Incontinence+4 More
Estradiol vaginal cream - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

The primary outcome of this study compare the rate of pessary discontinuation at 6 months post-pessary fitting in women using vaginal estradiol versus those not using vaginal estradiol.

Eligible Conditions

  • Urinary Incontinence
  • Atrophic
  • Ulcer
  • Pelvic Organ Prolapse

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 6 Months Post-Pessary Fitting

6 Months Post-Pessary Fitting
Pessary Discontinuation Rates
Phone calls/messages
Unscheduled office visits
Month 6
Pessary Discomfort
Vaginal Bleeding
Vaginal Discharge
Month 6
Urinary Tract Infection Rates
Vaginal Erosion Rates

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group
1 of 2
Estrogen Group
1 of 2
Active Control
Experimental Treatment

132 Total Participants · 2 Treatment Groups

Primary Treatment: Estradiol vaginal cream · No Placebo Group · Phase < 1

Estrogen Group
Drug
Experimental Group · 1 Intervention: Estradiol vaginal cream · Intervention Types: Drug
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol vaginal cream
2013
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months post-pessary fitting
Closest Location: University of South Florida · Tampa, FL
Photo of university of south florida 1Photo of university of south florida 2Photo of university of south florida 3
2015First Recorded Clinical Trial
2 TrialsResearching Urinary Incontinence
365 CompletedClinical Trials

Who is running the clinical trial?

University of South FloridaLead Sponsor
361 Previous Clinical Trials
99,437 Total Patients Enrolled
3 Trials studying Urinary Incontinence
156 Patients Enrolled for Urinary Incontinence
Alexandra N Garcia, MDPrincipal InvestigatorUniversity of South Florida

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are postmenopausal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.

References