Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
- Registration Number
- NCT03241342
- Lead Sponsor
- GTx
- Brief Summary
GTx-024 is an orally bioavailable and tissue-selective nonsteroidal selective androgen receptor modulator (SARM) that has demonstrated androgenic and anabolic activity and is currently being evaluated as a potential treatment for stress urinary incontinence (SUI) in postmenopausal women. Urinary incontinence and pelvic floor disorders are major health problems for women, especially as they age. Pelvic floor muscle relaxation has been found to correlate with lower urinary tract symptoms including SUI. Muscles of the pelvic floor and lower urinary tract are crucial for supporting the pelvic organs and micturition; however, damage to the muscles or lack of hormonal stimulation are thought to contribute to pelvic organ prolapse and urinary incontinence. Although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks have limited their use. Nonsteroidal SARMs have potential to achieve benefits of anabolic steroid therapy (improved muscle mass, cholesterol/triglyceride levels, glucose metabolism, and bone density) with fewer adverse effects, such as hirsutism and acne, in women. Both nonclinical and clinical data suggest that SARMs may provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite, dihydrotestosterone, have anabolic effects on muscle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 491
- SUI symptoms of at least 6 months duration
- Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.
- 24-Hour pad weight > 3 g during the screening period
- A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9 total SUI episodes over 3 days during the screening period
- Positive bladder stress test conducted during the Screening Visit
Key
- History of pelvic radiation treatment
- History of urethral diverticula
- History of urethral sling or anterior prolapse repair
- Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit
- Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities
- Urinary incontinence of neurogenic etiology
- Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater)
- Chronic hepatitis
- Hepatic cirrhosis
- Evidence of active infection with hepatitis B or hepatitis C
- History of human immunodeficiency virus (HIV) infection
- Subjects with a history of breast or endometrial cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 mg GTx-024 GTx 024 Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. 3 mg GTx-024 GTx 024 Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily. matching placebo Placebo Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.
- Primary Outcome Measures
Name Time Method Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12 12 Weeks Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a ≥ 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
William Beaumont Hospital Urology Research
🇺🇸Royal Oak, Michigan, United States
Circuit Clinical
🇺🇸West Seneca, New York, United States
Alliance Urology Specialist PA
🇺🇸Greensboro, North Carolina, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
James A Simon MD PC
🇺🇸Washington, District of Columbia, United States
Urology Center of Alabama
🇺🇸Homewood, Alabama, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Medical Research of Florida
🇺🇸Miami, Florida, United States
Precision Clinical Research
🇺🇸Lauderdale Lakes, Florida, United States
American Institute of Research
🇺🇸Whittier, California, 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
Lone Star Research Center
🇺🇸Miami, Florida, United States
Mount Vernon Clinical Research LLC
🇺🇸Sandy Springs, Georgia, United States
Idaho Urologic Institue
🇺🇸Meridian, Idaho, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Women's Health Institution of Illinois
🇺🇸Oak Lawn, Illinois, 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
Chesapeake Urology Associates PA
🇺🇸Hanover, Maryland, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Women's Clinic of Lincoln
🇺🇸Lincoln, Nebraska, United States
Bay State clinical Trials
🇺🇸Watertown, Massachusetts, United States
Accumed Research Associates
🇺🇸Garden City, New York, United States
Delaware Valley Urology
🇺🇸Mount Laurel, New Jersey, United States
American Health Research Inc
🇺🇸Charlotte, North Carolina, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Premier Urology Group, LL
🇺🇸Edison, New Jersey, United States
Eastern Carolina Women's
🇺🇸New Bern, North Carolina, United States
Institute for Female Pelvic Medicine
🇺🇸Allentown, Pennsylvania, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Urologic Consultants of Southeastern PA LLP
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Urology Northwest PS
🇺🇸Mountlake Terrace, Washington, United States
Elligo - Austin Area OBGYN
🇺🇸Austin, Texas, United States
Carolina Urologic Research
🇺🇸Myrtle Beach, South Carolina, United States
Seattle Womens: Health, Research, Gynocology
🇺🇸Seattle, Washington, United States
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
Women's Healthcare Research Corporation
🇺🇸San Diego, California, United States
Genitourinary Surgical Consultants
🇺🇸Denver, Colorado, United States
Sheldon J Freedman MD Ltd
🇺🇸Las Vegas, Nevada, United States
Clinical Trials of Texas Incorporated
🇺🇸San Antonio, Texas, United States
Urology San Antonio Research PA
🇺🇸San Antonio, Texas, United States
Urology Associates Research
🇺🇸Englewood, Colorado, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Bladder Control Center of Connecticut
🇺🇸Norwalk, Connecticut, United States
Premier Medical Group
🇺🇸Poughkeepsie, New York, United States
Lawrence Obs Gyn clinical Research
🇺🇸Lawrenceville, New Jersey, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
🇺🇸Layton, Utah, United States