Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Interventions
- Drug: Matching Placebo
- Registration Number
- NCT03508648
- Lead Sponsor
- GTx
- Brief Summary
The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching Placebo Matching Placebo Subjects previously enrolled in the placebo arm of study G201002. 3 mg GTx-024 GTx-024 Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002. 1 mg GTx-024 GTx-024 Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Durability of Response, urge incontinence baseline to 20 weeks Change from G201002 baseline in the mean number of urge incontinence episodes per day
Trial Locations
- Locations (46)
Urology Center of Alabama
🇺🇸Homewood, Alabama, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, 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
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Tampa Bay Medical Research Inc
🇺🇸Clearwater, Florida, United States
Midland Florida Clinical Research Center LLC
🇺🇸DeLand, Florida, United States
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