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Estrogen

Vaginal Estrogen for Urinary Tract Infections (PRUVE Trial)

Phase 4
Waitlist Available
Led By Victoria Handa, MD MHS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal women (menopausal for at least 1 year) of minimum age 55 years
Participants with documentation of recurrent UTI, defined as history of treatment for at least 3 UTIs in the past year or 2 episodes within 6 months AND at least one positive urine culture during an acute symptomatic episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12 to 24
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will investigate why vaginal estrogen therapy works for some post-menopausal women with recurrent UTI, to help prevent these infections.

Who is the study for?
This trial is for postmenopausal women aged 55 or older who have had at least 3 UTIs in the past year or 2 within the last 6 months, with one confirmed by urine culture. It's not for those currently on antibiotics to prevent UTIs, those with contraindications to vaginal estrogen, recent antibiotic use, complicated recurrent UTI due to other health issues.
What is being tested?
The study tests if vaginal estradiol tablets can prevent recurrent urinary tract infections in postmenopausal women. It examines how this treatment affects vaginal and bladder bacteria and immune responses to understand why it helps some women but not others.
What are the potential side effects?
Potential side effects of vaginal estradiol may include local irritation or discomfort, changes in discharge, and a slight increase in certain types of cancer risk as seen with other forms of estrogen therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 55 or older and have been postmenopausal for at least 1 year.
Select...
I have had 3 UTIs in the last year or 2 in the last 6 months, with at least one confirmed by a lab test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12 to 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12 to 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Urinary Interleukin-6 level
Change in Urinary microbiota
Change in Vaginal Interleukin-6 level
+1 more
Secondary study objectives
Urinary tract infection recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vaginal estrogen therapyExperimental Treatment1 Intervention
Participants receive Vaginal estrogen therapy.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,058 Total Patients Enrolled
6 Trials studying Urinary Tract Infection
1,472 Patients Enrolled for Urinary Tract Infection
Johns Hopkins UniversityLead Sponsor
2,332 Previous Clinical Trials
14,874,850 Total Patients Enrolled
University of MarylandOTHER
168 Previous Clinical Trials
304,891 Total Patients Enrolled
Victoria Handa, MD MHSPrincipal InvestigatorJohns Hopkins University

Media Library

Vaginal Estradiol Tablets (Estrogen) Clinical Trial Eligibility Overview. Trial Name: NCT05551949 — Phase 4
Urinary Tract Infection Research Study Groups: Vaginal estrogen therapy
Urinary Tract Infection Clinical Trial 2023: Vaginal Estradiol Tablets Highlights & Side Effects. Trial Name: NCT05551949 — Phase 4
Vaginal Estradiol Tablets (Estrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551949 — Phase 4
~9 spots leftby Aug 2025
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