Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Status:
Completed
Trial end date:
2018-09-21
Target enrollment:
Participant gender:
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.