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Hormone Therapy

Vaginal Estrogen for Urinary Tract Infection

Phase 4

Recruiting

Led By CHARLOTTE TER HAAR, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to understand how well women with low estrogen levels adhere to different types of vaginal estrogen treatments for recurrent urinary tract infections. They will also study changes in vaginal skin using a specialized imaging technique and

Who is the study for?

This trial is for hypoestrogenic women, typically post-menopausal, who frequently suffer from urinary tract infections. Participants should be willing to use one of three vaginal estrogen treatments and attend follow-up visits. Details about their health will be collected via questionnaires and medical tests.

What is being tested?

The study compares adherence to different forms of vaginal estrogen therapy: a cream (Estrace), tablets (Vagifem), or a drug-eluting ring (Estring). It also examines changes in the vagina's skin and microbiome using optical coherence tomography imaging and specimen collection.

What are the potential side effects?

Potential side effects may include local reactions like irritation or discomfort at the application site due to the vaginal estrogen products. The imaging procedure might cause some discomfort similar to that experienced during a pap smear.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and questionnaires will be collected at the baseline visit, 3 month follow-up and 6 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to vaginal estrogen treatment

Secondary study objectives

UTI rates

Urologic microbiome results for nested microbiome cohort

Vaginal health index for nested microbiome cohort

+9 more

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

3Treatment groups

Experimental Treatment

Group I: Estrogen tabletExperimental Treatment1 Intervention

Participants in this arm will receive the vaginal estrogen tablets (Vagifem) for treatment. Participants will place one tablet (10 mcg) into the vagina twice per week for the duration of the study.

Group II: Estrogen drug-eluting ringExperimental Treatment1 Intervention

Participants in this arm will receive the vaginal estrogen drug-eluting ring (Estring) for treatment. Participants will have the ring placed by a provider at their clinical visit. The ring will be exchanged every 12 weeks.

Group III: Estrogen creamExperimental Treatment1 Intervention

Participants in this arm will receive the vaginal estrogen cream (Estrace 0.01%) for treatment. Participants will apply 0.5gm twice per week for the duration of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vagifem

2016

Completed Phase 3

~310

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