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

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

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 Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: GTx 024; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: GTx 024; Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.; Other Names: Enobosarm
Active Comparator: 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.	Drug: GTx 024; Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.; Other Names: Enobosarm
Placebo Comparator: 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.	Drug: Placebo; Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GTx
• Investigators: Principal Investigator: Kenneth M Peters, MD, Oakland University, William Beaumont School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): September 21, 2018
• Study Completion (Actual): September 21, 2018

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: G201002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No