CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
Conjugated Estrogen Vaginal Cream +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01958073
NCT01958073Phase 4Completed

Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized Clinical Trial

University of California, San Diego·interventional·Posted Oct 8, 2013·Updated Sep 21, 2020

In Brief

A Phase 4 clinical trial evaluating Conjugated Estrogen Vaginal Cream, Estradiol Ring, and 1 other intervention for Recurrent Urinary Tract Infection. Completed, enrolled 35 participants across 2 sites.

Detailed Summary

The investigators would like to know if the use of vaginally applied estrogen can prevent the problem of repeated urinary tract infections (UTI) in women who have gone through menopause. The investigators will use two forms of vaginal estrogen that are available by prescription (a ring and a cream) and compare their efficacy to that of a placebo (without any active ingredient). The investigators are going to look at if the vaginal estrogen can prevent UTIs altogether and also the number of UTIs each group experiences over a 6 month period. After 6 months, all subjects will receive vaginal estrogen and the women on the non-active treatment will be able to choose whether they would like to use either the estrogen ring or cream. The investigators will then be able to compare the number of UTIs on and off active vaginal estrogen treatment within those subjects who started on the placebo. The investigators are also going to look at quality of life before and during treatment using questionnaires and whether subjects stop using the treatments or do not use them as directed (compliance).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartOct 1, 2013
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 12.7 years ago

Interventions

Conjugated Estrogen Vaginal Creamdrug

Estradiol Ringdrug

Placebodrug