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Estradiol vaginal cream for Vulvovaginal Atrophy

Phase < 1
Waitlist Available
Led By Alexandra N Garcia, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recent pessary fitting
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-pessary fitting
Awards & highlights

Study Summary

This trial compares the rate of pessary discontinuation in women using vaginal estradiol versus those not using it.

Eligible Conditions
  • Vulvovaginal Atrophy
  • Pelvic Organ Prolapse
  • Vaginal Pessary Ulcer
  • Urinary Incontinence

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You had a device called a pessary inserted recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-pessary fitting
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-pessary fitting for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pessary Discontinuation Rates
Secondary outcome measures
Pessary Discomfort
Phone calls/messages
Unscheduled office visits
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Estrogen GroupExperimental Treatment1 Intervention
Participants will receive standard pessary care, and those participants randomized to the experimental group will then be given a prescription for vaginal estradiol and instructed to apply it in the vagina nightly for two weeks and then twice weekly thereafter. Participation requires follow up visit 6 months from initial baseline visit. At this visit, participants are asked about vaginal bleeding, degree of bother due to vaginal discharge, and degree of pessary discomfort and a physical exam is performed.
Group II: Control GroupActive Control1 Intervention
Participants will receive standard pessary care. Participation requires follow up visit 6 months from initial baseline visit. At this visit, participants are asked about vaginal bleeding, degree of bother due to vaginal discharge, and degree of pessary discomfort and a physical exam is performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol vaginal cream
2013
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

University of South FloridaLead Sponsor
403 Previous Clinical Trials
185,183 Total Patients Enrolled
Alexandra N Garcia, MDPrincipal InvestigatorUniversity of South Florida

Frequently Asked Questions

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

Are there any available vacancies in this clinical trial?

"From the data provided by clinicaltrials.gov, this study is not presently recruiting participants. The trial was first made available on November 1st 2022 and last updated in October of that same year. Despite its current status, 227 other medical studies are still looking for volunteers at this time."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
University of South Florida
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Mar 2025