Phase
Condition
Overactive Bladder
Prostate Disorders
Enuresis
Treatment
Vibegron
Clinical Study ID
Ages > 45 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has completed participation of the 24-week double-blind treatment periodin Study URO-901-3005 (NCT03902080) and demonstrated compliance with the studyprocedures and study medication schedule in the opinion of the investigator.
Participant is capable of giving written informed consent, which includes compliancewith the requirements and restrictions listed in the consent form.
Participant has the ability to continue to receive a stable dose of Benign ProstaticHyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alphablocker +5-ARI.
In the opinion of the investigator, the participant is able and willing to complywith the requirements of the protocol, including completing study questionnaires andthe Bladder Diary.
Exclusion
Exclusion Criteria:
Participant experienced any Serious Adverse Event in Study URO-901-3005 that wasreported as "possibly or probably related" to study treatment by the investigator.
Participant is using any prohibited medications
Participant has uncontrolled hyperglycemia (defined as fasting blood glucose >150milligrams per deciliter [mg/dL] or 8.33 millimoles per Liter [mmol/L] and/ornon-fasting blood glucose >200 mg/dL or 11.1 mmol/L) based on most recent availablelab results in Study URO-901-3005 or uncontrolled in the opinion of theinvestigator.
Participant has uncontrolled hypertension (systolic blood pressure of ≥180millimeters of mercury [mmHg] and/or diastolic blood pressure of ≥100 mmHg) or has aresting heart rate (by pulse) >100 beats per minute.
Participant has systolic blood pressures ≥160 mmHg but <180 mmHg, unless deemed bythe investigator as safe to proceed in this study and able to complete the study perprotocol.
Participant has current evidence of any clinically significant condition, therapy,lab abnormality, or other circumstances that might, in the opinion of theinvestigator, confound the results of the study, interfere with the participant'sability to comply with study procedures, or make participation in the study not inthe participant's best interest.
Study Design
Connect with a study center
Centrum Medyczne Linden
Krakow,
PolandSite Not Available
Centrum Medyczne PROMED
Krakow,
PolandSite Not Available
Medicome Sp. z o.o.
Oswiecim,
PolandSite Not Available
Nzoz Heureka
Piaseczno,
PolandSite Not Available
Private Practice
Huntsville, Alabama 35801
United StatesSite Not Available
Coastal Clinical Research, Inc.
Mobile, Alabama 36608
United StatesSite Not Available
Clinical Trials Research
Lincoln, California 95648
United StatesSite Not Available
American Institute of Research
Los Angeles, California 90017
United StatesSite Not Available
Tri Valley Urology Medical Group
Murrieta, California 92562
United StatesSite Not Available
Northern California Research Corp
Sacramento, California 95821
United StatesSite Not Available
San Diego Clinical Trials
San Diego, California 91942
United StatesSite Not Available
Urology Specialists of Southern California (USSC)
Sherman Oaks, California 91411
United StatesSite Not Available
Skyline Urology
Torrance, California 90505
United StatesSite Not Available
Urology Associates - Urology
Denver, Colorado 80220
United StatesSite Not Available
Imagine Research of Palm Beach County - Urology
Boynton Beach, Florida 33435
United StatesSite Not Available
Tampa Bay Medical Research
Clearwater, Florida 33761
United StatesSite Not Available
Quantum Clinical Trials
Miami, Florida 33140
United StatesSite Not Available
Urology Center Of Florida
Pompano Beach, Florida 33060
United StatesSite Not Available
Precision Clinical Research
Sunrise, Florida 33351
United StatesSite Not Available
Clinical Research of Central Florida
Winter Haven, Florida 33880
United StatesSite Not Available
First Urology
Jeffersonville, Indiana 47130
United StatesSite Not Available
DelRicht Research
New Orleans, Louisiana 70115
United StatesSite Not Available
Regional Urology, LLC
Shreveport, Louisiana 71106
United StatesSite Not Available
Boston Clinical Trials Inc - Urology
Boston, Massachusetts 02131
United StatesSite Not Available
Mens Health Boston - Urology
Chestnut Hill, Massachusetts 02467
United StatesSite Not Available
Bay State Clinical Trials, Inc.
Watertown, Massachusetts 02472
United StatesSite Not Available
Beaumont Hospital Royal Oak - Urology Research
Royal Oak, Michigan 48703
United StatesSite Not Available
CentraCare Clinic - Adult & Pediatric Urology
Sartell, Minnesota 56377
United StatesSite Not Available
Poplar Bluff Urology
Poplar Bluff, Missouri 63901
United StatesSite Not Available
Adult & Pediatric Urology P.C. - Urology
Omaha, Nebraska 68114
United StatesSite Not Available
Excel Clinical Research - Internal Medicine
Las Vegas, Nevada 89109
United StatesSite Not Available
Private Practice
Las Vegas, Nevada 89144
United StatesSite Not Available
Premier Urology Group, LLC
Edison, New Jersey 08837
United StatesSite Not Available
New Jersey Urology NJU
Englewood, New Jersey 07631
United StatesSite Not Available
New Jersey Urology, LLC
Voorhees, New Jersey 08043
United StatesSite Not Available
AccuMed Research Associates
Garden City, New York 11530
United StatesSite Not Available
Urological Surgeons of Long Island
Garden City, New York 11530
United StatesSite Not Available
Manhattan Research Associates
New York, New York 10016
United StatesSite Not Available
Private Practice
Poughkeepsie, New York 12601
United StatesSite Not Available
Carolina Institute for Clinical Research
Fayetteville, North Carolina 27612
United StatesSite Not Available
Southwest Urology Inc
Cleveland, Ohio 44130
United StatesSite Not Available
Clinical Research Solutions
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Advances In Health, Inc.
Houston, Texas 77030
United StatesSite Not Available
Wasatch Clinical Research LLC
Salt Lake City, Utah 84107
United StatesSite Not Available
Seattle Urology Research Center
Burien, Washington 98166
United StatesSite Not Available
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