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Beta-3 Adrenergic Agonist

Vibegron for Overactive Bladder

Phase 3
Waitlist Available
Research Sponsored by Urovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 12
Awards & highlights

Study Summary

This trial will compare the effectiveness of vibegron to a placebo in men with overactive bladder who are also taking medication for benign prostatic hyperplasia.

Eligible Conditions
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline at Week 12 in the average number of micturition episodes per day
Change from Baseline at Week 12 in the average number of urgency episodes (need to urinate immediately) per day
Secondary outcome measures
Change from Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage score (1-week recall)
Change from Baseline at Week 12 in the average number of nocturia episodes per night
Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline
+1 more

Side effects data

From 2019 Phase 3 trial • 506 Patients • NCT03583372
9%
Hypertension
7%
Urinary tract infection
5%
Dry mouth
5%
Nasopharyngitis
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Tolterodine ER 4 mg
Overall Vibegron 75 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vibegron 75 mgExperimental Treatment1 Intervention
Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo orally once daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibegron
2018
Completed Phase 3
~3520

Find a Location

Who is running the clinical trial?

Urovant Sciences GmbHLead Sponsor
10 Previous Clinical Trials
3,159 Total Patients Enrolled
Rachael Jankowich, RN, MSNStudy DirectorUrovant Sciences
1 Previous Clinical Trials
276 Total Patients Enrolled
Study DirectorStudy DirectorUrovant Sciences
1,214 Previous Clinical Trials
498,409 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other similar clinical trials exist for this condition?

"Vibegron has only undergone one clinical trial as of 2019. The study, sponsored by Urovant Sciences GmbH, was completed in Phase 3 and involved 1088 participants from 97 cities across 8 countries."

Answered by AI

Is Vibegron a common medication in research?

"There is currently one clinical trial evaluating the efficacy of Vibegron. That study is in Phase 3. Though the initial research for this medication was conducted in Leuven, there are now 140 sites running trials across the world."

Answered by AI

Are there any limits to the number of patients who can join this trial?

"As specified in the study's inclusion criteria, 1088 patients are required to participate. The sponsor, Urovant Sciences GmbH, will be conducting the trial at various locations; two of these sites include Norris Comprehensive Cancer Center (Los Angeles, California) and San Diego Clinical Trials (La Mesa, Florida)."

Answered by AI

At how many different sites can patients enroll in this research trial?

"To make the study as convenient as possible for participants, 42 clinical trial sites have been set up in Los Angeles, La Mesa, Miami and other locations. You will be asked to choose the location closest to you when enrolling."

Answered by AI

When will Vibegron be available commercially?

"Vibegron, which is currently in Phase 3 trials, received a safety score of 3. This rating reflects the presence of both efficacy and safety data from multiple rounds of testing."

Answered by AI

Who else is applying?

What state do they live in?
Utah
What site did they apply to?
Wasatch Clinical Research LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
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)
2019. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03902080.
~182 spots leftby May 2025
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