Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
NCT ID: NCT03508648
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-05-28
2018-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Matching Placebo
Subjects previously enrolled in the placebo arm of study G201002.
Matching Placebo
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
1 mg GTx-024
Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.
GTx-024
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
3 mg GTx-024
Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.
GTx-024
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Interventions
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GTx-024
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Matching Placebo
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
* Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study
Exclusion Criteria
* Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results
18 Years
80 Years
FEMALE
No
Sponsors
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GTx
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
Locations
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Urology Center of Alabama
Homewood, Alabama, United States
Coastal Clinical Research Inc
Mobile, Alabama, United States
Alaska Clinical Research Center
Anchorage, Alaska, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Urology Associates Research
Englewood, Colorado, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Tampa Bay Medical Research Inc
Clearwater, Florida, United States
Midland Florida Clinical Research Center LLC
DeLand, Florida, United States
Medical Research of Florida
Miami, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Mount Vernon Clinical Research LLC
Sandy Springs, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Idaho Urologic Institue
Meridian, Idaho, United States
First Urology PSC
Jeffersonville, Indiana, United States
Iowa Clinic
West Des Moines, Iowa, United States
DelRicht Clinical Research, LLC
New Orleans, Louisiana, United States
Regional Urology
Shreveport, Louisiana, United States
Chesapeake Urology Associates PA
Hanover, Maryland, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Bay State Clinical Trials
Watertown, Massachusetts, United States
Beyer Research
Kalamazoo, Michigan, United States
William Beaumont Hospital Urology Research
Royal Oak, Michigan, United States
Women's Clinic of Lincoln
Lincoln, Nebraska, United States
Sheldon J Freedman MD Ltd
Las Vegas, Nevada, United States
Premier Urology Group, LL
Edison, New Jersey, United States
Lawrence Obs Gyn clinical Research
Lawrenceville, New Jersey, United States
Delaware Valley Urology
Mount Laurel, New Jersey, United States
Accumed Research Associates
Garden City, New York, United States
Manhattan Medical Research Practice PLLC
New York, New York, United States
Circuit Clinical
West Seneca, New York, United States
American Health Research Inc
Charlotte, North Carolina, United States
Eastern Carolina Women's
New Bern, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Aventiv Research
Columbus, Ohio, United States
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, United States
Urologic Consultants of Southeastern PA LLP
Bala-Cynwyd, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
Elligo - Austin Area OBGYN
Austin, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Urology San Antonio Research PA
San Antonio, Texas, United States
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
Layton, Utah, United States
Seattle Womens: Health, Research, Gynocology
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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G201003
Identifier Type: -
Identifier Source: org_study_id
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