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NCT03902080 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Urovant Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,105
- Enrollment target
NCT03902080: Completed Phase 3 study, sponsored by Urovant Sciences.
NCT03902080 is a Phase 3 study that has completed, run by Urovant Sciences. The registered enrollment target is 1,105 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03902080, a Phase 3 study, has completed, sponsored by Urovant Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,105 participants
- Enrollment target
Study 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.
Primary Outcome
Micturition was defined as the number of times a participant voided in the toilet as indicated on the Bladder Diary. Baseline was defined as the last non-missing result on or prior to the randomization date. Change from baseline was calculated as the post-baseline value minus the baseline value. Daily Averages were calculated as the sum of the event type on Complete Diary Days divided by the number of Complete Diary Days.
Interventions
- DRUG Placebo
- DRUG Vibegron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,105 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2023-06-15 |
| Phase | Phase 3 |
What the finished NCT03902080 record still lists
NCT03902080 is an interventional study that assigns participants to a tested intervention. Its 1,105 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03902080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03902080 about?
NCT03902080 is a clinical study titled "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)". 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.
What is the current status of trial NCT03902080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,105 participants. The study started on 2019-03-26. Estimated completion is 2023-06-15.
What interventions are being tested in trial NCT03902080?
The interventions under investigation include: Placebo (DRUG), Vibegron (DRUG).
Who is sponsoring clinical trial NCT03902080?
This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03902080's enrollment target sits among peer trials
1,105 251st of 2000 higher than 1,749 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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