Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Status: | Completed |
---|---|
Conditions: | Urology, Urology |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 9/27/2018 |
Start Date: | August 21, 2017 |
End Date: | September 21, 2018 |
Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
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.
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 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
We found this trial at
62
sites
1 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
Bala-Cynwyd, Pennsylvania 19004
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