Back to resultsStudy to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence (ASTRID)
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GTx 024
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
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
Sites / Locations
- Urology Center of Alabama
- Coastal Clinical Research Inc
- Alaska Clinical Research Center
- Mayo Clinic Arizona
- Urological Associates of Southern Arizona
- Women's Healthcare Research Corporation
- American Institute of Research
- Genitourinary Surgical Consultants
- Urology Associates Research
- Women's Health Specialty Care
- Coastal Connecticut Research, LLC
- Bladder Control Center of Connecticut
- James A Simon MD PC
- South Florida Medical Research
- Tampa Bay Medical Research Inc
- Midland Florida Clinical Research Center LLC
- Precision Clinical Research
- Lone Star Research Center
- Medical Research of Florida
- Clinical Research Center of Florida
- Mount Vernon Clinical Research LLC
- Clinical Research Prime
- Idaho Urologic Institue
- Women's Health Institution of Illinois
- First Urology PSC
- Iowa Clinic
- DelRicht Clinical Research, LLC
- Regional Urology
- Chesapeake Urology Associates PA
- Boston Clinical Trials
- Bay State clinical Trials
- Beyer Research
- William Beaumont Hospital Urology Research
- Women's Clinic of Lincoln
- Sheldon J Freedman MD Ltd
- Premier Urology Group, LL
- Lawrence Obs Gyn clinical Research
- Delaware Valley Urology
- Accumed Research Associates
- Manhattan Medical Research Practice PLLC
- Premier Medical Group
- Circuit Clinical
- American Health Research Inc
- Alliance Urology Specialist PA
- Eastern Carolina Women's
- The Urology Group
- Cleveland Clinic
- Aventiv Research
- Institute for Female Pelvic Medicine
- Urologic Consultants of Southeastern PA LLP
- University of Pennsylvania Health System
- Coastal Carolina Research Center
- Carolina Urologic Research
- The Jackson Clinic
- Elligo - Austin Area OBGYN
- Urology Clinics of North Texas
- Clinical Trials of Texas Incorporated
- Urology San Antonio Research PA
- Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
- Urology of Virginia
- Urology Northwest PS
- Seattle Womens: Health, Research, Gynocology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1 mg GTx-024
3 mg GTx-024
matching placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241342
Brief Title
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Acronym
ASTRID
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
September 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GTx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 mg GTx-024
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3 mg GTx-024
Arm Type
Active Comparator
Arm Description
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.
Arm Title
matching placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GTx 024
Other Intervention Name(s)
Enobosarm
Intervention Description
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
Primary Outcome Measure Information:
Title
Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12
Description
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
Time Frame
12 Weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Peters, MD
Organizational Affiliation
Oakland University, William Beaumont School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Center of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Urological Associates of Southern Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Women's Healthcare Research Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Urology Associates Research
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Bladder Control Center of Connecticut
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06859
Country
United States
Facility Name
James A Simon MD PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Tampa Bay Medical Research Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Midland Florida Clinical Research Center LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Precision Clinical Research
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Lone Star Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Medical Research of Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Mount Vernon Clinical Research LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Idaho Urologic Institue
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Women's Health Institution of Illinois
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
First Urology PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
DelRicht Clinical Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Associates PA
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Bay State clinical Trials
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
William Beaumont Hospital Urology Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Women's Clinic of Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Sheldon J Freedman MD Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Premier Urology Group, LL
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Lawrence Obs Gyn clinical Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Delaware Valley Urology
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Premier Medical Group
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Circuit Clinical
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
American Health Research Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Alliance Urology Specialist PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Eastern Carolina Women's
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Institute for Female Pelvic Medicine
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urologic Consultants of Southeastern PA LLP
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Carolina Urologic Research
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Elligo - Austin Area OBGYN
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Clinical Trials of Texas Incorporated
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Urology San Antonio Research PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Urology Northwest PS
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Seattle Womens: Health, Research, Gynocology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
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