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

NCT ID: NCT03241342

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-21
• Study Completion Date: 2018-09-21

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1 mg GTx-024

Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.

Group Type: ACTIVE_COMPARATOR

GTx 024

Intervention Type: DRUG

Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.

3 mg GTx-024

Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.

Group Type: ACTIVE_COMPARATOR

GTx 024

Intervention Type: DRUG

Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.

matching placebo

Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.

Interventions

GTx 024

Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.

Intervention Type: DRUG

Placebo

Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.

Intervention Type: DRUG

Other Intervention Names

Enobosarm

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GTx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth M Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Oakland University, William Beaumont School of Medicine

Locations

Urology Center of Alabama

Homewood, Alabama, United States

Coastal Clinical Research Inc

Mobile, Alabama, United States

Alaska Clinical Research Center

Anchorage, Alaska, United States

Mayo Clinic Arizona

Phoenix, Arizona, United States

Urological Associates of Southern Arizona

Tucson, Arizona, United States

Women's Healthcare Research Corporation

San Diego, California, United States

American Institute of Research

Whittier, California, 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

Bladder Control Center of Connecticut

Norwalk, Connecticut, United States

James A Simon MD PC

Washington D.C., District of Columbia, 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

Precision Clinical Research

Lauderdale Lakes, Florida, United States

Lone Star Research Center

Miami, Florida, United States

Medical Research of Florida

Miami, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

Mount Vernon Clinical Research LLC

Sandy Springs, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Idaho Urologic Institue

Meridian, Idaho, United States

Women's Health Institution of Illinois

Oak Lawn, Illinois, United States

First Urology PSC

Jeffersonville, Indiana, United States

Iowa Clinic

West Des Moines, Iowa, United States

DelRicht Clinical Research, LLC

New Orleans, Louisiana, United States

Regional Urology

Shreveport, Louisiana, United States

Chesapeake Urology Associates PA

Hanover, Maryland, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Bay State clinical Trials

Watertown, Massachusetts, United States

Beyer Research

Kalamazoo, Michigan, United States

William Beaumont Hospital Urology Research

Royal Oak, Michigan, United States

Women's Clinic of Lincoln

Lincoln, Nebraska, United States

Sheldon J Freedman MD Ltd

Las Vegas, Nevada, United States

Premier Urology Group, LL

Edison, New Jersey, United States

Lawrence Obs Gyn clinical Research

Lawrenceville, New Jersey, United States

Delaware Valley Urology

Mount Laurel, New Jersey, United States

Accumed Research Associates

Garden City, New York, United States

Manhattan Medical Research Practice PLLC

New York, New York, United States

Premier Medical Group

Poughkeepsie, New York, United States

Circuit Clinical

West Seneca, New York, United States

American Health Research Inc

Charlotte, North Carolina, United States

Alliance Urology Specialist PA

Greensboro, North Carolina, United States

Eastern Carolina Women's

New Bern, North Carolina, United States

The Urology Group

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Aventiv Research

Columbus, Ohio, United States

Institute for Female Pelvic Medicine

Allentown, Pennsylvania, United States

Urologic Consultants of Southeastern PA LLP

Bala-Cynwyd, Pennsylvania, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Carolina Urologic Research

Myrtle Beach, South Carolina, United States

The Jackson Clinic

Jackson, Tennessee, United States

Elligo - Austin Area OBGYN

Austin, Texas, United States

Urology Clinics of North Texas

Dallas, Texas, United States

Clinical Trials of Texas Incorporated

San Antonio, Texas, United States

Urology San Antonio Research PA

San Antonio, Texas, United States

Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice

Layton, Utah, United States

Urology of Virginia

Virginia Beach, Virginia, United States

Urology Northwest PS

Mountlake Terrace, Washington, United States

Seattle Womens: Health, Research, Gynocology

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

G201002

Identifier Type: -

Identifier Source: org_study_id