Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

• GTx-024 (Drug), also known as enobosarm: Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
• Matching Placebo (Drug): Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.

Primary outcomes

• Durability of Response, stress incontinence [baseline to 20 weeks]: Change from G201002 baseline in the mean number of stress incontinence episodes per day
• Durability of Response, patient global impression of severity [baseline to 20 weeks]: Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)
• Durability of Response, patient global impression of improvement [baseline to 20 weeks]: Change from G201002 baseline in patient global impression of improvement scale (PGI-I; scale: 1-very much better, 2-much better, 3-a little better, 4-no change, 5-a little worse, 6-much worse, 7-very much worse; representing change in urinary tract dysfunction from initiation of therapy)

Secondary outcomes

• Durability of Response, urge incontinence [baseline to 20 weeks]: Change from G201002 baseline in the mean number of urge incontinence episodes per day
• Durability of Response, total incontinence [baseline to 20 weeks]: Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day

Sex: Female, ages: 18 Years to 80 Years

Inclusion Criteria:

* Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods
* Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
* Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study

Exclusion Criteria:

* Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation
* Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results

• Study Protocol (PDF, 2015-08-07)

• Kenneth Peters, MD, Principal investigator, Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine