Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Completed · Phase 2 · Has a placebo group
Conditions studied: Stress Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT03241342
- Run by
- GTx
- People needed
- 491
- Starts
- 2017-08-21
- Expected to finish
- 2018-09-21
- Last updated by the study team
- 2021-03-24
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Coastal Clinical Research Inc — Mobile, Alabama, United States
- Alaska Clinical Research Center — Anchorage, Alaska, United States
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- Urological Associates of Southern Arizona — Tucson, Arizona, United States
- Women's Healthcare Research Corporation — San Diego, California, United States
- American Institute of Research — Whittier, California, 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
- Bladder Control Center of Connecticut — Norwalk, Connecticut, United States
- James A Simon MD PC — Washington D.C., District of Columbia, 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
- Precision Clinical Research — Lauderdale Lakes, Florida, United States
- Lone Star Research Center — Miami, 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
- Women's Health Institution of Illinois — Oak Lawn, Illinois, United States
- First Urology PSC — Jeffersonville, Indiana, United States
- Urology Center of Alabama — Homewood, Alabama, United States
Full record on ClinicalTrials.gov
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