Back to resultsStudy to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vibegron
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (ß3-AR), ß3-AR agonist
Eligibility Criteria
Inclusion Criteria:
- Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
- Participant has an International Prostate Symptom Score total score of ≥ 8
- Participant has a prostate-specific antigen level < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator
- Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period
- Participant must have a post void residual volume value of < 100 mL
- Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.
Exclusion Criteria:
- Participant has a history of 24-hour urine volume greater than 3,000 mL
- Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
- Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
- Has a history of urinary retention requiring an intervention (e.g., catheterization) for any reason
- Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL
- Has a history of or current nocturnal polyuria
- Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
- Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
- Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute (min)
- Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit
- Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
- Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with the study procedure, or make participation in the study not in the participant's best interest
Sites / Locations
- Urology Centers of Alabama
- Private Practice
- Coastal Clinical Research, Inc.
- Gen1 Research- Arizona Urology Specialists
- Urological Associates Of Southern Arizona
- California Research Medical Group, Inc.
- San Diego Clinical Trials
- Clinical Trials Research
- West Coast Urology
- American Institute of Research
- Norris Comprehensive Cancer Center
- Tri Valley Urology Medical Group
- Northern California Research Corp
- Medical Center for Clinical Research
- Urology Specialists of Southern California (USSC)
- Skyline Urology
- Urology Associates - Urology
- Imagine Research of Palm Beach County - Urology
- Tampa Bay Medical Research
- Urological Research Network Corp
- LCC Medical Research Institute
- Quantum Clinical Trials
- Private Practice
- Urology Center Of Florida
- Pinellas Urology, Inc.
- Precision Clinical Research
- Florida Urology Partners, LLP
- Clinical Research of Central Florida
- Meridian Clinical Research - Urology
- Idaho Urologic Institute
- NorthShore University Health System
- First Urology
- The Iowa Clinic
- GU Research Network/Wichita Urology Group
- DelRicht Research
- Regional Urology, LLC
- Chesapeake Urology Research Associates
- Boston Clinical Trials Inc - Urology
- Mens Health Boston - Urology
- Bay State Clinical Trials, Inc.
- Beaumont Hospital Royal Oak - Urology Research
- CentraCare Clinic - Adult & Pediatric Urology
- Poplar Bluff Urology
- Adult & Pediatric Urology P.C. - Urology
- Excel Clinical Research - Internal Medicine
- Private Practice
- Premier Urology Group, LLC
- New Jersey Urology NJU
- New Jersey Urology, LLC
- New Jersey Urology, LLC
- Albany Medical College
- Western New York Urology Associates
- AccuMed research Asociates
- Urological Surgeons of Long Island
- Manhattan Research Associates
- Columbia University Medical Center - Clinical Research
- Weill Cornell Medicine
- Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
- Private Practice
- Duke Medical Center - Urology
- Carolina Institute for Clinical Research
- Alliance Urology Specialists - Greensboro
- Triad Clinical Trials
- Peters Medical Research
- Associated Urologists of North Carolina - Urology
- Clinical Research Solutions
- Lowcountry Urology
- Urology Clinics of North Texas
- Advances In Health, Inc.
- Urology San Antonio
- Discovery Clinical Trials
- Baylor Scott & White Medical Center
- Wasatch Clinical Research LLC
- Urology of Virginia (UVA)
- Seattle Urology Research Center
- Uz Antwerpen
- Algemeen Stedelijk Ziekenhuis
- Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
- AZ Maria Middelares - Campus Maria Middelares
- UZ Leuven - Campus Gasthuisberg
- AZ Delta - Campus Wilgenstraat
- CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
- Private Practice
- Bluewater Clinical Research Group Inc
- Sunnybrook Health Sciences Center
- Toronto Western Hospital
- Diex Research Quebec Inc.
- Centre Hospitalier Universitaire De Sherbrooke (CHUS)
- Diex Research Sherbrooke Inc.
- Diex Research Victoriaville Inc.
- University of Szeged
- DRC Kft.
- Semmelweis Egyetem
- Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
- Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
- Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
- Uro-Clin Kft.
- Szent Borbala Korhaz
- Kaunas Hospital of Lithuanian Universoity of Health Sciences
- JSC Saules seimos medicinos centras
- Uab "Vakk"
- Hospital of University of Health Sciences Kauno Klinikos
- Respublikine Klaipedos ligonine - Urology
- Klaipedos Universitetine Ligonine (Klaipeda Hospital)
- National Cancer Institute
- Republican Vilnius University Hospital
- Vilnius University Hospital Santariskiu Klinikos
- Vilnius City Clinical Hospital
- EuroMediCare Szpital Specjalistyczny z Przychodnia
- Wojewodzki Szpital Specjalist
- Nasz Lekarz Osrodek Badan Klinicznych
- NZOZ Specjalista
- ETG Lodz
- Centrum Medyczne PROMED
- Szpital Specjalistyczny Slupsk
- Centrum Urologiczne sp. z o.o.
- Clinical Research Center Sp. z o.o., Medic-R Sp. K.
- Centrum Medyczne Linden
- Medicome Sp. z o.o.
- Nzoz Heureka
- Lexmedica Hanna Durbajlo-Gradziel
- Hospital Garcia de Orta
- Centro Clínico Académico Braga, Hospital de Braga
- Hospital Senhora de Oliveiro Guimaraes EPE
- H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
- Hospital de Santa Maria
- H. Santo António. Centro Hospitalar do Porto
- Hospital Santiago Apostol
- Hospital Universitario Fundación Alcorcón
- Hospital Universitario HM Monteprincipe
- Hospital General Universitario Gregorio Marañón
- Hospital Universitario Puerta de Hierro Majadahonda
- Hospital Universitario Infanta Sofía
- Hospital del Mar
- Hospital Universitario Reina Sofia
- Clínica Universitaria de Navarra
- Hospital Universitario 12 de Octubre
- H.U. Virgen de la Victoria
- Hospital Universitario de Salamanca
- Hospital Universitari i Politecnic La Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vibegron 75 mg
Placebo
Arm Description
Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Participants will receive matching placebo orally once daily for 24 weeks.
Outcomes
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 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
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 volume voided per micturition
Full Information
NCT ID
NCT03902080
First Posted
April 1, 2019
Last Updated
September 21, 2023
Sponsor
Urovant Sciences GmbH
1. Study Identification
Unique Protocol Identification Number
NCT03902080
Brief 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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urovant Sciences GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Benign Prostatic Hyperplasia, Vibegron, Beta-3 adrenergic receptor (ß3-AR), ß3-AR agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibegron 75 mg
Arm Type
Experimental
Arm Description
Participants will receive vibegron 75 milligrams (mg) orally once daily for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive matching placebo orally once daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Vibegron
Other Intervention Name(s)
RVT-901, MK-4618, KRP-114V, URO-901
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Change from Baseline at Week 12 in the average number of micturition episodes per day
Time Frame
Baseline; Week 12
Title
Change from Baseline at Week 12 in the average number of urgency episodes (need to urinate immediately) per day
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline at Week 12 in the average number of nocturia episodes per night
Time Frame
Baseline; Week 12
Title
Change from Baseline at Week 12 in the average number of urge urinary incontinence episodes per day for participants with urinary incontinence at Baseline
Time Frame
Baseline; Week 12
Title
Change from Baseline at Week 12 in the International Prostate Symptom Score (IPSS) Storage score (1-week recall)
Time Frame
Baseline; Week 12
Title
Change from Baseline at Week 12 in the average volume voided per micturition
Time Frame
Baseline; Week 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant should have been on and agree to continue to stay on a stable dose of benign prostatic hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker + 5 alpha reductase inhibitor.
Participant has an International Prostate Symptom Score total score of ≥ 8
Participant has a prostate-specific antigen level < 4 nanograms per milliliter (ng/mL), or if ≥ 4 ng/mL but ≤ 10 ng/mL, prostate cancer has been ruled out to the satisfaction of the investigator
Participant must have both additional qualifications based on the 3-day Bladder Diary period: a) having an average of ≥ 8 but ≤ 20 micturition episodes per day over the 3-day diary period, and (b) having an average of ≥ 3 urgency episodes per day over the 3-day diary period
Participant must have a post void residual volume value of < 100 mL
Having at least 2 average nocturia episodes per night based on 3-day Bladder Diary at baseline. Nocturia is defined as waking to pass urine during the main sleep period.
Exclusion Criteria:
Participant has a history of 24-hour urine volume greater than 3,000 mL
Has lower urinary tract pathology that could, in the opinion of the investigator, be responsible for urgency, frequency, or incontinence
Has a history of prostate surgery, including minimally invasive transurethral or transrectal procedures, procedural treatments for BPH within 6 months of Screening or has a planned prostate surgery
Has a history of urinary retention requiring an intervention (e.g., catheterization) for any reason
Has maximum urinary flow (Qmax) < 5.0 mL/second with a minimum voided volume of 125 mL
Has a history of or current nocturnal polyuria
Has an active or recurrent (> 3 episodes per year) urinary tract infection by clinical symptoms or laboratory criteria (≥ 5 white blood cells/high power field [hpf] with presence of red blood cell [RBC] and/or a positive urine culture, defined as ≥ 10^5 colony forming units (CFU)/mL (i.e., 100 × 10^3 CFU/mL in a single specimen)
Has uncontrolled hyperglycemia (defined as fasting blood glucose > 150 milligrams per deciliter (mg/dL) or 8.33 millimoles per liter (mmol/L) or non-fasting blood glucose > 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the investigator, is uncontrolled
Has uncontrolled hypertension (systolic blood pressure of ≥ 180 millimeters of mercury (mmHg) and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) > 100 beats per minute (min)
Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions [e.g., angioplasty, stent insertion]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit
Has alanine aminotransferase or aspartate aminotransferase > 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) > 1.5 × ULN (or > 2.0 × ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome)
Has an estimated glomerular filtration rate < 30 mL/min/1.73 meters squared (m^2)
Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with the study procedure, or make participation in the study not in the participant's best interest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Urovant Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Private Practice
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Gen1 Research- Arizona Urology Specialists
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Urological Associates Of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
California Research Medical Group, Inc.
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
San Diego Clinical Trials
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
West Coast Urology
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Tri Valley Urology Medical Group
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Northern California Research Corp
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Urology Specialists of Southern California (USSC)
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91411
Country
United States
Facility Name
Skyline Urology
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Urology Associates - Urology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Imagine Research of Palm Beach County - Urology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Urological Research Network Corp
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
LCC Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Quantum Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Private Practice
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Urology Center Of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Pinellas Urology, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Precision Clinical Research
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Florida Urology Partners, LLP
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Meridian Clinical Research - Urology
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Idaho Urologic Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
NorthShore University Health System
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
First Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
The Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
GU Research Network/Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Boston Clinical Trials Inc - Urology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Mens Health Boston - Urology
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Beaumont Hospital Royal Oak - Urology Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48703
Country
United States
Facility Name
CentraCare Clinic - Adult & Pediatric Urology
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
Poplar Bluff Urology
City
Poplar Bluff
State/Province
Missouri
ZIP/Postal Code
63901
Country
United States
Facility Name
Adult & Pediatric Urology P.C. - Urology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Excel Clinical Research - Internal Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Private Practice
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Premier Urology Group, LLC
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
New Jersey Urology NJU
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
New Jersey Urology, LLC
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
New Jersey Urology, LLC
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Western New York Urology Associates
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
AccuMed research Asociates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Research Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center - Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Advanced Urology Centers of NY, A Division of Integrated Medical Professionals (IMP)
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Private Practice
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Duke Medical Center - Urology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Alliance Urology Specialists - Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Triad Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Associated Urologists of North Carolina - Urology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Lowcountry Urology
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Advances In Health, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Urology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Baylor Scott & White Medical Center
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Wasatch Clinical Research LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Urology of Virginia (UVA)
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Seattle Urology Research Center
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Uz Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
02650
Country
Belgium
Facility Name
Algemeen Stedelijk Ziekenhuis
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
09300
Country
Belgium
Facility Name
Onze-Lieve-Vrouwziekenhuis VZW - Campus Aalst
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
09300
Country
Belgium
Facility Name
AZ Maria Middelares - Campus Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
09000
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
03000
Country
Belgium
Facility Name
AZ Delta - Campus Wilgenstraat
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
08800
Country
Belgium
Facility Name
CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie
City
Liège
ZIP/Postal Code
04000
Country
Belgium
Facility Name
Private Practice
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 4S5
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Diex Research Quebec Inc.
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Centre Hospitalier Universitaire De Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Diex Research Victoriaville Inc.
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
University of Szeged
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
06725
Country
Hungary
Facility Name
DRC Kft.
City
Sopron
State/Province
Gyor-Moson-Sopron
ZIP/Postal Code
H-9400
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
01082
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
City
Budapest
ZIP/Postal Code
01204
Country
Hungary
Facility Name
Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
City
Csongrad
ZIP/Postal Code
06640
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
City
Nyiregyhaza
ZIP/Postal Code
04400
Country
Hungary
Facility Name
Uro-Clin Kft.
City
Pècs
ZIP/Postal Code
07621
Country
Hungary
Facility Name
Szent Borbala Korhaz
City
Tatabanya
ZIP/Postal Code
02800
Country
Hungary
Facility Name
Kaunas Hospital of Lithuanian Universoity of Health Sciences
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-47144
Country
Lithuania
Facility Name
JSC Saules seimos medicinos centras
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-49449
Country
Lithuania
Facility Name
Uab "Vakk"
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-50128
Country
Lithuania
Facility Name
Hospital of University of Health Sciences Kauno Klinikos
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-50161
Country
Lithuania
Facility Name
Respublikine Klaipedos ligonine - Urology
City
Klaipeda
State/Province
Klaipedos Apskritis
ZIP/Postal Code
LT-92231
Country
Lithuania
Facility Name
Klaipedos Universitetine Ligonine (Klaipeda Hospital)
City
Klaipeda
State/Province
Klaipedos Apskritis
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
State/Province
Vilniaus Apskritis
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
Republican Vilnius University Hospital
City
Vilnius
State/Province
Vilniaus Apskritis
ZIP/Postal Code
LT-08660
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
State/Province
Vilniaus Apskritis
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Vilnius City Clinical Hospital
City
Vilnius
State/Province
Vilniaus Apskritis
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
EuroMediCare Szpital Specjalistyczny z Przychodnia
City
Wroclaw
State/Province
Dolnoslaskie Województwo
ZIP/Postal Code
54-144
Country
Poland
Facility Name
Wojewodzki Szpital Specjalist
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-650
Country
Poland
Facility Name
NZOZ Specjalista
City
Kutno
State/Province
Lódzkie
ZIP/Postal Code
99-300
Country
Poland
Facility Name
ETG Lodz
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centrum Medyczne PROMED
City
Krakow
State/Province
Malopolskie Województwo
ZIP/Postal Code
31-513
Country
Poland
Facility Name
Szpital Specjalistyczny Slupsk
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Centrum Urologiczne sp. z o.o.
City
Myslowice
State/Province
Silesia
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-856
Country
Poland
Facility Name
Centrum Medyczne Linden
City
Krakow
ZIP/Postal Code
37-721
Country
Poland
Facility Name
Medicome Sp. z o.o.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Nzoz Heureka
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Lexmedica Hanna Durbajlo-Gradziel
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Centro Clínico Académico Braga, Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Hospital Senhora de Oliveiro Guimaraes EPE
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
H. Egas Moniz. Centro Hospitalar Lisboa Ocidental
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
H. Santo António. Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital Santiago Apostol
City
Miranda de Ebro
State/Province
Burgos
ZIP/Postal Code
09200
Country
Spain
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Universitario HM Monteprincipe
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Infanta Sofía
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
H.U. Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Urovant is committed to sharing patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Data requests will be reviewed and approved on the basis of scientific merit. All data provided will be anonymized according to applicable laws and regulations.
IPD Sharing Time Frame
The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
IPD Sharing Access Criteria
Access to these clinical trial data can be requested by emailing medinfo@urovant.com and will be provided following Urovant review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
Learn more about this trial
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)
We'll reach out to this number within 24 hrs