CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 84 enrolled
Drug / intervention
Mirabegrondrug
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/NCT02495389
NCT02495389Phase 4Completed
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Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome

Loyola University·interventional·Posted Jul 13, 2015·Updated Nov 13, 2020

In Brief

A Phase 4 clinical trial evaluating Mirabegron for Overactive Bladder. Completed, enrolled 84 participants across 1 site.

Detailed Summary

This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to estimate the number of women who respond to a medication called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment and change in symptom severity over 12 weeks of therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
CollaboratorsAstellas Pharma US, Inc.

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 13, 2015
Enrollment StartJan 28, 2015
Primary CompletionJan 29, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.0 years ago

Interventions

Mirabegrondrug

Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.