Clinical trial NCT03241342: Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Lead sponsor: GTx
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 491
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Center of Alabama
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona
state: Arizona
city: San Diego
country: United States
facility: Women's Healthcare Research Corporation
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Englewood
country: United States
facility: Urology Associates Research
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Norwalk
country: United States
facility: Bladder Control Center of Connecticut
state: Connecticut
city: Washington
country: United States
facility: James A Simon MD PC
state: District of Columbia
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center LLC
state: Florida
city: Lauderdale Lakes
country: United States
facility: Precision Clinical Research
state: Florida
city: Miami
country: United States
facility: Lone Star Research Center
state: Florida
city: Miami
country: United States
facility: Medical Research of Florida
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institue
state: Idaho
city: Oak Lawn
country: United States
facility: Women's Health Institution of Illinois
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Associates PA
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Bay State clinical Trials
state: Massachusetts
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital Urology Research
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon J Freedman MD Ltd
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group, LL
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence Obs Gyn clinical Research
state: New Jersey
city: Mount Laurel
country: United States
facility: Delaware Valley Urology
state: New Jersey
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group
state: New York
city: West Seneca
country: United States
facility: Circuit Clinical
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialist PA
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern PA LLP
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Austin
country: United States
facility: Elligo - Austin Area OBGYN
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Incorporated
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research PA
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
state: Utah
city: Virginia Beach
country: United States
facility: Urology of Virginia
state: Virginia
city: Mountlake Terrace
country: United States
facility: Urology Northwest PS
state: Washington
city: Seattle
country: United States
facility: Seattle Womens: Health, Research, Gynocology
state: Washington
Study officials:
affiliation: Oakland University, William Beaumont School of Medicine
name: Kenneth M Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: