NCT03902080

Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,105 (actual)
• Sponsor: Urovant Sciences GmbH · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Vibegron	oral administration
DRUG	Placebo	oral administration

Timeline

• Start date: 2019-03-26
• Primary completion: 2023-06-15
• Completion: 2023-06-15
• First posted: 2019-04-03
• Last updated: 2024-08-07
• Results posted: 2024-08-07

Locations

140 sites across 8 countries: United States, Belgium, Canada, Hungary, Lithuania, Poland, Portugal, Spain

Regulatory

• FDA-regulated drug study