CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Tolterodine ER 4mg +2 moredrug
Likely dose
Tolterodine ER 4mgfrom 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/NCT00939120
NCT00939120Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Study of Safety and Efficacy of Dutasteride in Combination With Tolterodine ER or Placebo in Men With Lower Urinary Tract Symptoms (LUTS) Including Urgency and Frequency

Siami, Paul F., M.D.·interventional·Posted Jul 14, 2009·Updated May 1, 2015

In Brief

A Phase 4 clinical trial evaluating Tolterodine ER 4mg, Placebo, and 1 other intervention for Benign Prostatic Hyperplasia (BPH). Completed, enrolled 46 participants across 1 site.

Detailed Summary

This is an investigator-initiated study of safety, efficacy and tolerability of dutasteride given for 18 months, including a 1-year double-blind randomized co-administration with either tolterodine ER or placebo in men suffering from lower urinary tract symptoms (LUTS) including urgency and frequency, with or without urgency urinary incontinence (i.e., overactive bladder (OAB) symptoms).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia (BPH)
CountriesUnited States
CollaboratorsGlaxoSmithKline, Pfizer

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.0 years ago

Interventions

Tolterodine ER 4mgdrug

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4 mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Placebodrug

1:1 randomization to either Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily or Dutasteride 0.5mg orally once daily plus placebo once daily

Pre-randomization Dutasteridedrug

All participants were on Dutasteride 0.5mg orally once daily prior to randomization.