Trial · 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)
NCT03902080, Phase 3, Completed, Urovant Sciences GmbH; results first posted 2024-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT03902080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03902080
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT03902080
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,105 participants, actual
- Lead sponsor
- Urovant Sciences GmbH
- Conditions
- Overactive Bladder
- Interventions
- Vibegron, Placebo
- First posted
- 2019-04-03
- Last updated
- 2024-08-07
- Other registries' IDs
- eudract:2018-003135-30
- Results first posted
- 2024-08-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day | Baseline; Week 12 | 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. |
| Primary | Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day | Baseline; Week 12 | Urgency was defined as the number of times a participant checked that they had the need to urinate immediately 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. |
| Secondary | Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night | Baseline; Week 12 | Nocturia was defined as waking to pass urine during the main sleep period. 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. |
| Secondary | Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline | Baseline; Week 12 | The number of UUI episodes was defined as the number of times a subject checked that they had "urge" as the main reason for leakage. Average UUI episodes per day at each study visit was calculated as total number of UUI episodes within the diary analysis visit windows divided by non-missing diary days. 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. |
| Secondary | Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | Baseline; Week 12 | The IPSS is based on the responses to 7 questions concerning urinary symptoms and 1 question concerning quality of life. Each question concerning urinary symptoms allows the participant to choose 1 out of 6 answers indicating increasing severity of the particular symptom. The responses are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Higher numerical scores represent greater severity of symptoms. Decrease in IPSS storage score indicates improvement. 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. |
| Secondary | Change From Baseline at Week 12 in the Average Volume Voided Per Micturition | Baseline; Week 12 | 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. Average volume voided per micturition at each study visit was calculated as the total volume voided over diary days within the analysis visit window divided by the total number of micturition episodes during non-missing diary days. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day | Baseline; Week 12 | Full Analysis Set. Only those participants with data available at specified time points have been presented. | Micturitions per day | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day | Baseline; Week 12 | Full Analysis Set. Only those participants with data available at specified time points have been presented. | Urgency Episodes per Day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night | Baseline; Week 12 | Full Analysis Set. Only those participants with data available at specified time points have been presented. | Nocturia episodes per night | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline | Baseline; Week 12 | Full Analysis Set for Incontinence (FAS-I) consists of all randomized participants with incontinence at baseline who took at least one dose of double-blind study medication, have an evaluable baseline urgency urinary incontinence measurement, and have at least one evaluable change from baseline urgency urinary incontinence measurement. Only those participants with data available at specified time points have been presented. | UUI Episodes Per Day | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | Baseline; Week 12 | Full Analysis Set. Only those participants with data available at specified time points have been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 12 in the Average Volume Voided Per Micturition | Baseline; Week 12 | Full Analysis Set. Only those participants with data available at specified time points have been presented. | mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day | Vibegron 75 Milligrams (mg) Once Daily (QD) | -2.04 | Standard Error 0.109 | Micturitions per day | |
| Change From Baseline at Week 12 in the Average Number of Micturition Episodes Per Day | Placebo | -1.30 | Standard Error 0.109 | Micturitions per day | |
| Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day | Vibegron 75 Milligrams (mg) Once Daily (QD) | -2.88 | Standard Error 0.164 | Urgency Episodes per Day | |
| Change From Baseline at Week 12 in the Average Number of Urgency Episodes (Need to Urinate Immediately) Per Day | Placebo | -1.93 | Standard Error 0.164 | Urgency Episodes per Day | |
| Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night | Vibegron 75 Milligrams (mg) Once Daily (QD) | -0.88 | Standard Error 0.054 | Nocturia episodes per night | |
| Change From Baseline at Week 12 in the Average Number of Nocturia Episodes Per Night | Placebo | -0.66 | Standard Error 0.054 | Nocturia episodes per night | |
| Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline | Vibegron 75 Milligrams (mg) Once Daily (QD) | -2.19 | Standard Error 0.210 | UUI Episodes Per Day | |
| Change From Baseline at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per Day for Participants With Urinary Incontinence at Baseline | Placebo | -1.39 | Standard Error 0.202 | UUI Episodes Per Day | |
| Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | Vibegron 75 Milligrams (mg) Once Daily (QD) | -3.0 | Standard Error 0.13 | Scores on a scale | |
| Change From Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage Score (1-week Recall) | Placebo | -2.2 | Standard Error 0.13 | Scores on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vibegron 75 Milligrams (mg) Once Daily (QD) | 551 | |
| Overall Study | STARTED | Placebo | 554 | |
| Overall Study | Received at Least 1 Dose of Double-blind Medication | Vibegron 75 Milligrams (mg) Once Daily (QD) | 551 | |
| Overall Study | Received at Least 1 Dose of Double-blind Medication | Placebo | 553 | |
| Overall Study | COMPLETED | Vibegron 75 Milligrams (mg) Once Daily (QD) | 484 | |
| Overall Study | COMPLETED | Placebo | 481 | |
| Overall Study | NOT COMPLETED | Vibegron 75 Milligrams (mg) Once Daily (QD) | 67 | |
| Overall Study | NOT COMPLETED | Placebo | 73 |
Source ClinicalTrials.gov
Adverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Vibegron 75 Milligrams (mg) Once Daily (QD) | 22 | 553 | 22 |
| other | COVID-19 | Infections and infestations | Placebo | 17 | 551 | 17 |
| other | Urinary tract infection | Infections and infestations | Vibegron 75 Milligrams (mg) Once Daily (QD) | 14 | 553 | 15 |
| other | Urinary tract infection | Infections and infestations | Placebo | 12 | 551 | 13 |
| other | Hypertension | Vascular disorders | Vibegron 75 Milligrams (mg) Once Daily (QD) | 50 | 553 | 53 |
| other | Hypertension | Vascular disorders | Placebo | 46 | 551 | 46 |
| other | Haematuria | Renal and urinary disorders | Vibegron 75 Milligrams (mg) Once Daily (QD) | 11 | 553 | 11 |
| other | Haematuria | Renal and urinary disorders | Placebo | 14 | 551 | 15 |
| serious | Acute kidney injury | Renal and urinary disorders | Vibegron 75 Milligrams (mg) Once Daily (QD) | 1 | 553 | 1 |
| serious | Acute kidney injury | Renal and urinary disorders | Placebo | 0 | 551 | 0 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vibegron 75 Milligrams (mg) Once Daily (QD) | 0 | 553 |
| Total, all-cause mortality | Placebo | 0 | 551 |
| Total, other adverse events | Vibegron 75 Milligrams (mg) Once Daily (QD) | 79 | 553 |
| Total, other adverse events | Placebo | 71 | 551 |
| Total, serious adverse events | Vibegron 75 Milligrams (mg) Once Daily (QD) | 24 | 553 |
| Total, serious adverse events | Placebo | 16 | 551 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41363221 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vibegron 75 Milligrams (mg) Once Daily (QD) vs Placebo: deaths from any cause | Trial comparisons |
| Vibegron 75 Milligrams (mg) Once Daily (QD) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03902080
GET https://conductscience.org/api/trials/v1/NCT03902080/events?page=2