Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

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

Locations (62): Urology Center of Alabama
🇺🇸
Homewood, Alabama, United States
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
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Urology Center of Alabama
🇺🇸Homewood, Alabama, United States