Stress urinary incontinence is the unintentional and involuntary loss of urine caused by pelvic floor muscle weakness
The ability of a SARM to increase muscle mass may prove beneficial in postmenopausal women with stress urinary incontinence (SUI) where pelvic floor muscle weakness leads to unintentional loss of urine with physical activity.
The Company has completed a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with Stress Urinary Incontinence (SUI). The study, called ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder) recruited patients at various clinical trial centers across the United States. In September 2018, the Company announced that the study did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to placebo. Top-line results from the ASTRID trial may be found here.
In a Phase 2 proof-of-concept clinical trial, data from which were announced in September 2017, a daily dose of enobosarm 3 mg (GTx-024) substantially improved SUI in women, as well as related quality of life measurements. Top-line results from the Phase 2 proof-of-concept trial may be found here.
More information on Stress Urinary Incontinence may be found here.