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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

PRUVE Trial 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.Check my eligibility

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.See study design

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.

PRUVE Trial 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.

PRUVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 12 to 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Urinary Interleukin-6 level

Change in Urinary microbiota

Change in Vaginal Interleukin-6 level

+1 more

Secondary outcome measures

Urinary tract infection recurrence

PRUVE Trial Design

1Treatment groups

Experimental Treatment

Group I: Vaginal estrogen therapyExperimental Treatment1 Intervention

Participants receive Vaginal estrogen therapy.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,357 Previous Clinical Trials

4,315,136 Total Patients Enrolled

8 Trials studying Urinary Tract Infection

1,569 Patients Enrolled for Urinary Tract Infection

Johns Hopkins UniversityLead Sponsor

2,258 Previous Clinical Trials

14,820,483 Total Patients Enrolled

1 Trials studying Urinary Tract Infection

University of MarylandOTHER

160 Previous Clinical Trials

302,233 Total Patients Enrolled

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

Frequently Asked Questions

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

Is this research endeavor accommodating geriatric patients?

"This clinical trial has established the age-limit of 55 to 100 years old, thus excluding minors and patients over 65 from enrollment. There are 360 studies open for participants under 18 and 1,554 suited for those above 65."

Answered by AI

To what degree does this treatment present a danger to participants?

"There is existing evidence that this treatment is safe, so it has been rated a 3 on our scale. This corresponds to the fact that its Phase 4 status indicates approval from relevant authorities."

Answered by AI

What criteria must be met for individuals to qualify as participants in this clinical trial?

"This clinical trial is currently seeking 50 candidates between the age of 55 and 100, who are suffering from urinary tract infection."

Answered by AI

Are there any available vacancies for individuals to join this experiment?

"Based on the information reported on clinicaltrials.gov, recruitment for this study has temporarily paused since it was last updated in November of 2023. However, 1853 other medical trials across different specialties are actively enrolling patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Recurrent UTI With Vaginal Estrogen

2023. "Preventing Recurrent UTI With Vaginal Estrogen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05551949.

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