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Hormone Therapy

Estrogen drug-eluting ring 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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Adherence to vaginal estrogen treatment

Secondary outcome measures

UTI rates

Urologic microbiome results for nested microbiome cohort

Vaginal health index for nested microbiome cohort

+9 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor

544 Previous Clinical Trials

1,922,932 Total Patients Enrolled

1 Trials studying Urinary Tract Infection

59 Patients Enrolled for Urinary Tract Infection

CHARLOTTE TER HAAR, MDPrincipal InvestigatorUniversity of California, Irvine

Olivia Chang, MDStudy DirectorUniversity of California, Irvine

Frequently Asked Questions

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

What is the current number of participants being admitted to this clinical study?

"Indeed, details on clinicaltrials.gov highlight the ongoing patient recruitment for this trial. Initially listed on April 1st, 2024, and last modified on April 5th, 2024, the study aims to enroll a total of 111 participants from one site."

Answered by AI

Are patients currently able to participate in this ongoing medical study?

"According to the details provided on clinicaltrials.gov, this particular research investigation is actively seeking eligible individuals. The trial was first published on April 1st, 2024 and underwent its most recent revision on April 5th, 2024."

Answered by AI

Has the Estrogen tablet been certified by the FDA for use?

"The safety rating for the Estrogen tablet in this Phase 4 trial is categorized as a level 3 by our team at Power, indicating that the treatment has already obtained approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections

Charlotte Ter Haar 2024. "Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06353269.

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