Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence



Status:Completed
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:9/27/2018
Start Date:August 21, 2017
End Date:September 21, 2018

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Double-Blind, Placebo-Controlled, Parallel Design, Phase 2 Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

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.


Key Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
62
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Poughkeepsie, New York 12601
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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Allentown, Pennsylvania 18103
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Anchorage, Alaska 99508
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Austin, Texas 78758
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Aventura, Florida 33180
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1 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
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Boston, Massachusetts 02135
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Charlotte, North Carolina 28207
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Cincinnati, Ohio 45212
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Clearwater, Florida 33761
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Columbus, Ohio 43213
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Dallas, Texas 75231
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DeLand, FL
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Denver, Colorado 80220
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10 Parsonage Road
Edison, New Jersey 08837
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Englewood, Colorado
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Farmington, Connecticut 06032
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Garden City, New York 11530
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Greensboro, North Carolina 27403
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7580 Buckingham Boulevard
Hanover, Maryland 21076
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Homewood, Alabama
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Idaho Falls, Idaho 83404
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Jackson, Tennessee 38301
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Jeffersonville, Indiana 47130
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Kalamazoo, Michigan 49009
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Las Vegas, Nevada 89148
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4700 North State Road 7
Lauderdale Lakes, Florida 33319
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Lawrenceville, New Jersey 08648
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Lincoln, Nebraska 68510
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Meridian, Idaho 83642
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Miami, Florida 33145
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Miami, Florida 33186
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Mobile, Alabama 36608
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Mount Laurel, New Jersey 08054
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Mount Pleasant, South Carolina 29464
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Mountlake Terrace, Washington 98043
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Myrtle Beach, South Carolina 29572
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801 McCarthy Boulevard
New Bern, North Carolina 28562
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3525 Prytania Street
New Orleans, Louisiana 70115
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New York, New York 10016
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Norwalk, Connecticut 06859
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5851 95th Street
Oak Lawn, Illinois 60453
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85054
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Pompano Beach, Florida 33060
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31157 Woodward Avenue
Royal Oak, Michigan 48073
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San Antonio, Texas 78229
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San Antonio, Texas 78229
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3750 Convoy Street
San Diego, California 92111
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Sandy Springs, Georgia 30328
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3216 Northeast 45th Place
Seattle, Washington 98105
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Shreveport, Louisiana 71106
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Virginia Beach, Virginia 23462
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Washington, District of Columbia 20036
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Watertown, Massachusetts 02472
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West Des Moines, Iowa 50266
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599 Delaware Avenue
West Seneca, New York 14224
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Whittier, California 90603
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