CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Extended Release Tolterodine LA +1 moredrug
Likely dose
Extended Release Tolterodine LA 4 mgfrom 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/NCT00465894
NCT00465894N/ACompleted

Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women

University of Alabama at Birmingham·interventional·Posted Apr 25, 2007·Updated Nov 1, 2018

In Brief

A clinical study evaluating Extended Release Tolterodine LA and Intra Vaginal Estradiol Cream for Overactive Bladder. Completed, enrolled 58 participants.

Detailed Summary

The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsPfizer

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2007
Enrollment StartApr 1, 2007
Primary CompletionJul 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.2 years ago

Interventions

Extended Release Tolterodine LAdrug

Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks

Intra Vaginal Estradiol Creamdrug

17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.