Status:
COMPLETED
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Lead Sponsor:
GTx
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2018
Estimated Enrollment :
491 Patients enrolled
Trial Details
Trial ID
NCT03241342
Start Date
August 21 2017
End Date
September 21 2018
Last Update
March 24 2021
Active Locations (62)
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1
Urology Center of Alabama
Homewood, Alabama, United States, 35209
2
Coastal Clinical Research Inc
Mobile, Alabama, United States, 36608
3
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99503
4
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054