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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT03241342

Public ClinicalTrials.gov record NCT03241342. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03241342
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
GTx
Industry
Enrollment
491 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 21, 2017 (Actual)
Primary completion
Sep 21, 2018 (Actual)
Completion
Sep 21, 2018 (Actual)
Last update posted
Mar 24, 2021

2017 – 2018

United States locations

U.S. sites
62
U.S. states
30
U.S. cities
60
Facility City State ZIP Site status
Urology Center of Alabama Homewood Alabama 35209 —
Coastal Clinical Research Inc Mobile Alabama 36608 —
Alaska Clinical Research Center Anchorage Alaska 99503 —
Mayo Clinic Arizona Phoenix Arizona 85054 —
Urological Associates of Southern Arizona Tucson Arizona 85741 —
Women's Healthcare Research Corporation San Diego California 92111 —
American Institute of Research Whittier California 90603 —
Genitourinary Surgical Consultants Denver Colorado 80220 —
Urology Associates Research Englewood Colorado 80113 —
Women's Health Specialty Care Farmington Connecticut 06032 —
Coastal Connecticut Research, LLC New London Connecticut 06320 —
Bladder Control Center of Connecticut Norwalk Connecticut 06859 —
James A Simon MD PC Washington D.C. District of Columbia 20036 —
South Florida Medical Research Aventura Florida 33180 —
Tampa Bay Medical Research Inc Clearwater Florida 33761 —
Midland Florida Clinical Research Center LLC DeLand Florida 32720 —
Precision Clinical Research Lauderdale Lakes Florida 33319 —
Lone Star Research Center Miami Florida 33145 —
Medical Research of Florida Miami Florida 33186 —
Clinical Research Center of Florida Pompano Beach Florida 33060 —
Mount Vernon Clinical Research LLC Sandy Springs Georgia 30328 —
Clinical Research Prime Idaho Falls Idaho 83221 —
Idaho Urologic Institue Meridian Idaho 83642 —
Women's Health Institution of Illinois Oak Lawn Illinois 60453 —
First Urology PSC Jeffersonville Indiana 47130 —
Iowa Clinic West Des Moines Iowa 50266 —
DelRicht Clinical Research, LLC New Orleans Louisiana 70115 —
Regional Urology Shreveport Louisiana 71106 —
Chesapeake Urology Associates PA Hanover Maryland 21076 —
Boston Clinical Trials Boston Massachusetts 02131 —
Bay State clinical Trials Watertown Massachusetts 02472 —
Beyer Research Kalamazoo Michigan 49009 —
William Beaumont Hospital Urology Research Royal Oak Michigan 48073 —
Women's Clinic of Lincoln Lincoln Nebraska 68510 —
Sheldon J Freedman MD Ltd Las Vegas Nevada 89144 —
Premier Urology Group, LL Edison New Jersey 08837 —
Lawrence Obs Gyn clinical Research Lawrenceville New Jersey 08648 —
Delaware Valley Urology Mount Laurel New Jersey 08054 —
Accumed Research Associates Garden City New York 11530 —
Manhattan Medical Research Practice PLLC New York New York 10016 —
Premier Medical Group Poughkeepsie New York 12601 —
Circuit Clinical West Seneca New York 14224 —
American Health Research Inc Charlotte North Carolina 28207 —
Alliance Urology Specialist PA Greensboro North Carolina 27403 —
Eastern Carolina Women's New Bern North Carolina 28562 —
The Urology Group Cincinnati Ohio 45212 —
Cleveland Clinic Cleveland Ohio 44195 —
Aventiv Research Columbus Ohio 43213 —
Institute for Female Pelvic Medicine Allentown Pennsylvania 18103 —
Urologic Consultants of Southeastern PA LLP Bala-Cynwyd Pennsylvania 19004 —
University of Pennsylvania Health System Philadelphia Pennsylvania 19104 —
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464 —
Carolina Urologic Research Myrtle Beach South Carolina 29572 —
The Jackson Clinic Jackson Tennessee 38305 —
Elligo - Austin Area OBGYN Austin Texas 78758 —
Urology Clinics of North Texas Dallas Texas 75231 —
Clinical Trials of Texas Incorporated San Antonio Texas 78229 —
Urology San Antonio Research PA San Antonio Texas 78229 —
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice Layton Utah 84041 —
Urology of Virginia Virginia Beach Virginia 23462 —
Urology Northwest PS Mountlake Terrace Washington 98043 —
Seattle Womens: Health, Research, Gynocology Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03241342, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 24, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03241342 live on ClinicalTrials.gov.

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