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

NCT03241342 | Completed Phase 2 Results FDA Drug

• 1 other identifier: G201002
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 62

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

1 mg GTx-024

ACTIVE COMPARATOR

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.

Drug: GTx 024

3 mg GTx-024

ACTIVE COMPARATOR

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.

Drug: GTx 024

matching placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

GTx 024 DRUG

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

Also known as: Enobosarm

1 mg GTx-024; 3 mg GTx-024

Placebo DRUG

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

matching placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female, 18 to 80 years of age, inclusive, at screening; having undergone spontaneous, medically induced, or surgical menopause prior to the start of the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GTx: lead

Study Sites (62)

Urology Center of Alabama

Homewood, Alabama, 35209, United States

Location

Coastal Clinical Research Inc

Mobile, Alabama, 36608, United States

Location

Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Urological Associates of Southern Arizona

Tucson, Arizona, 85741, United States

Location

Women's Healthcare Research Corporation

San Diego, California, 92111, United States

Location

American Institute of Research

Whittier, California, 90603, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

Urology Associates Research

Englewood, Colorado, 80113, United States

Location

Women's Health Specialty Care

Farmington, Connecticut, 06032, United States

Location

Coastal Connecticut Research, LLC

New London, Connecticut, 06320, United States

Location

Bladder Control Center of Connecticut

Norwalk, Connecticut, 06859, United States

Location

James A Simon MD PC

Washington D.C., District of Columbia, 20036, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Tampa Bay Medical Research Inc

Clearwater, Florida, 33761, United States

Location

Midland Florida Clinical Research Center LLC

DeLand, Florida, 32720, United States

Location

Precision Clinical Research

Lauderdale Lakes, Florida, 33319, United States

Location

Lone Star Research Center

Miami, Florida, 33145, United States

Location

Medical Research of Florida

Miami, Florida, 33186, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Mount Vernon Clinical Research LLC

Sandy Springs, Georgia, 30328, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83221, United States

Location

Idaho Urologic Institue

Meridian, Idaho, 83642, United States

Location

Women's Health Institution of Illinois

Oak Lawn, Illinois, 60453, United States

Location

First Urology PSC

Jeffersonville, Indiana, 47130, United States

Location

Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

DelRicht Clinical Research, LLC

New Orleans, Louisiana, 70115, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Associates PA

Hanover, Maryland, 21076, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Bay State clinical Trials

Watertown, Massachusetts, 02472, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

William Beaumont Hospital Urology Research

Royal Oak, Michigan, 48073, United States

Location

Women's Clinic of Lincoln

Lincoln, Nebraska, 68510, United States

Location

Sheldon J Freedman MD Ltd

Las Vegas, Nevada, 89144, United States

Location

Premier Urology Group, LL

Edison, New Jersey, 08837, United States

Location

Lawrence Obs Gyn clinical Research

Lawrenceville, New Jersey, 08648, United States

Location

Delaware Valley Urology

Mount Laurel, New Jersey, 08054, United States

Location

Accumed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research Practice PLLC

New York, New York, 10016, United States

Location

Premier Medical Group

Poughkeepsie, New York, 12601, United States

Location

Circuit Clinical

West Seneca, New York, 14224, United States

Location

American Health Research Inc

Charlotte, North Carolina, 28207, United States

Location

Alliance Urology Specialist PA

Greensboro, North Carolina, 27403, United States

Location

Eastern Carolina Women's

New Bern, North Carolina, 28562, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Institute for Female Pelvic Medicine

Allentown, Pennsylvania, 18103, United States

Location

Urologic Consultants of Southeastern PA LLP

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Carolina Urologic Research

Myrtle Beach, South Carolina, 29572, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

Elligo - Austin Area OBGYN

Austin, Texas, 78758, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Clinical Trials of Texas Incorporated

San Antonio, Texas, 78229, United States

Location

Urology San Antonio Research PA

San Antonio, Texas, 78229, United States

Location

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

Layton, Utah, 84041, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Urology Northwest PS

Mountlake Terrace, Washington, 98043, United States

Location

Seattle Womens: Health, Research, Gynocology

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

ostarine

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mary Breitmeyer
• Organization: Oncternal

MBreitmeyer@oncternal.com

858-434-1113

Study Officials

• Kenneth M Peters, MD

  Oakland University, William Beaumont School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, parallel design, randomized, multicenter, Phase 2 study consisting of the following periods: screening period, treatment period, and follow-up period.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: August 21, 2017
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: March 24, 2021
• Results First Posted: November 12, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (62)