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

Stress Urinary Incontinence Clinical Trial

— ASTRID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241342
• Other study ID #: G201002
• Status: Completed
• Phase: Phase 2
• Start date: August 21, 2017
• Est. completion date: September 21, 2018

Study information

• Verified date: March 2021
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: September 21, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• GTx 024
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
• Placebo
Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine	Allentown	Pennsylvania
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	Elligo - Austin Area OBGYN	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Consultants of Southeastern PA LLP	Bala-Cynwyd	Pennsylvania
United States	Boston Clinical Trials	Boston	Massachusetts
United States	American Health Research Inc	Charlotte	North Carolina
United States	The Urology Group	Cincinnati	Ohio
United States	Tampa Bay Medical Research Inc	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Aventiv Research	Columbus	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Midland Florida Clinical Research Center LLC	DeLand	Florida
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Premier Urology Group, LL	Edison	New Jersey
United States	Urology Associates Research	Englewood	Colorado
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Accumed Research Associates	Garden City	New York
United States	Alliance Urology Specialist PA	Greensboro	North Carolina
United States	Chesapeake Urology Associates PA	Hanover	Maryland
United States	Urology Center of Alabama	Homewood	Alabama
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	The Jackson Clinic	Jackson	Tennessee
United States	First Urology PSC	Jeffersonville	Indiana
United States	Beyer Research	Kalamazoo	Michigan
United States	Sheldon J Freedman MD Ltd	Las Vegas	Nevada
United States	Precision Clinical Research	Lauderdale Lakes	Florida
United States	Lawrence Obs Gyn clinical Research	Lawrenceville	New Jersey
United States	Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice	Layton	Utah
United States	Women's Clinic of Lincoln	Lincoln	Nebraska
United States	Idaho Urologic Institue	Meridian	Idaho
United States	Lone Star Research Center	Miami	Florida
United States	Medical Research of Florida	Miami	Florida
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	Delaware Valley Urology	Mount Laurel	New Jersey
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Urology Northwest PS	Mountlake Terrace	Washington
United States	Carolina Urologic Research	Myrtle Beach	South Carolina
United States	Eastern Carolina Women's	New Bern	North Carolina
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	DelRicht Clinical Research, LLC	New Orleans	Louisiana
United States	Manhattan Medical Research Practice PLLC	New York	New York
United States	Bladder Control Center of Connecticut	Norwalk	Connecticut
United States	Women's Health Institution of Illinois	Oak Lawn	Illinois
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Premier Medical Group	Poughkeepsie	New York
United States	William Beaumont Hospital Urology Research	Royal Oak	Michigan
United States	Clinical Trials of Texas Incorporated	San Antonio	Texas
United States	Urology San Antonio Research PA	San Antonio	Texas
United States	Women's Healthcare Research Corporation	San Diego	California
United States	Mount Vernon Clinical Research LLC	Sandy Springs	Georgia
United States	Seattle Womens: Health, Research, Gynocology	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	Urological Associates of Southern Arizona	Tucson	Arizona
United States	Urology of Virginia	Virginia Beach	Virginia
United States	James A Simon MD PC	Washington	District of Columbia
United States	Bay State clinical Trials	Watertown	Massachusetts
United States	Iowa Clinic	West Des Moines	Iowa
United States	Circuit Clinical	West Seneca	New York
United States	American Institute of Research	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a = 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12	Mean number of subject-reported stress incontinence episodes per day through a responder analysis, where a responder is defined as having a = 50% reduction at the end of treatment (Week 12) compared to baseline in the number of stress incontinence episodes	12 Weeks