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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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,932,937 Total Patients Enrolled
CHARLOTTE TER HAAR, MDPrincipal InvestigatorUniversity of California, Irvine
Olivia Chang, MDStudy DirectorUniversity of California, Irvine