Stress Urinary IncontinencePhase 2ASTRIDNCT03241342
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
A Phase 2 study testing GTx 024 in people with Stress Urinary Incontinence, run by GTx at 62 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- GTx 024
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- 62 sitesUnited States
- Study dates
- 21 Aug 2017to 21 Sep 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, 18103
Alaska Clinical Research Center
Anchorage, Alaska, 99503
Elligo - Austin Area OBGYN
Austin, Texas, 78758
South Florida Medical Research
Aventura, Florida, 33180
Urologic Consultants of Southeastern PA LLP
Bala-Cynwyd, Pennsylvania, 19004
Boston Clinical Trials
Boston, Massachusetts, 02131
American Health Research Inc
Charlotte, North Carolina, 28207
The Urology Group
Cincinnati, Ohio, 45212
Tampa Bay Medical Research Inc
Clearwater, Florida, 33761
Cleveland Clinic
Cleveland, Ohio, 44195
Aventiv Research
Columbus, Ohio, 43213
Urology Clinics of North Texas
Dallas, Texas, 75231
Midland Florida Clinical Research Center LLC
DeLand, Florida, 32720
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Premier Urology Group, LL
Edison, New Jersey, 08837
Urology Associates Research
Englewood, Colorado, 80113
Women's Health Specialty Care
Farmington, Connecticut, 06032
Accumed Research Associates
Garden City, New York, 11530
Alliance Urology Specialist PA
Greensboro, North Carolina, 27403
Chesapeake Urology Associates PA
Hanover, Maryland, 21076
Urology Center of Alabama
Homewood, Alabama, 35209
Clinical Research Prime
Idaho Falls, Idaho, 83221
The Jackson Clinic
Jackson, Tennessee, 38305
First Urology PSC
Jeffersonville, Indiana, 47130
Beyer Research
Kalamazoo, Michigan, 49009
Sheldon J Freedman MD Ltd
Las Vegas, Nevada, 89144
Precision Clinical Research
Lauderdale Lakes, Florida, 33319
Lawrence Obs Gyn clinical Research
Lawrenceville, New Jersey, 08648
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
Layton, Utah, 84041
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510
Idaho Urologic Institue
Meridian, Idaho, 83642
Lone Star Research Center
Miami, Florida, 33145
Medical Research of Florida
Miami, Florida, 33186
Coastal Clinical Research Inc
Mobile, Alabama, 36608
Delaware Valley Urology
Mount Laurel, New Jersey, 08054
Urology Northwest PS
Mountlake Terrace, Washington, 98043
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Carolina Urologic Research
Myrtle Beach, South Carolina, 29572
Eastern Carolina Women's
New Bern, North Carolina, 28562
Coastal Connecticut Research, LLC
New London, Connecticut, 06320
DelRicht Clinical Research, LLC
New Orleans, Louisiana, 70115
Manhattan Medical Research Practice PLLC
New York, New York, 10016
Bladder Control Center of Connecticut
Norwalk, Connecticut, 06859
Women's Health Institution of Illinois
Oak Lawn, Illinois, 60453
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Premier Medical Group
Poughkeepsie, New York, 12601
William Beaumont Hospital Urology Research
Royal Oak, Michigan, 48073
Clinical Trials of Texas Incorporated
San Antonio, Texas, 78229
Urology San Antonio Research PA
San Antonio, Texas, 78229
Women's Healthcare Research Corporation
San Diego, California, 92111
Mount Vernon Clinical Research LLC
Sandy Springs, Georgia, 30328
Seattle Womens: Health, Research, Gynocology
Seattle, Washington, 98105
Regional Urology
Shreveport, Louisiana, 71106
Urological Associates of Southern Arizona
Tucson, Arizona, 85741
Urology of Virginia
Virginia Beach, Virginia, 23462
James A Simon MD PC
Washington D.C., District of Columbia, 20036
Bay State clinical Trials
Watertown, Massachusetts, 02472
Iowa Clinic
West Des Moines, Iowa, 50266
Circuit Clinical
West Seneca, New York, 14224
American Institute of Research
Whittier, California, 90603
About this study
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
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
- Being tested
- GTx 024, Placebo
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTx 024Drug
Also called Enobosarm
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
PlaceboDrug
Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start21 Aug 2017
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth M Peters, MD, Principal investigator, Oakland University, William Beaumont School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241342
- Sponsor's protocol ID
- G201002
- Acronym
- ASTRID
- Status last verified
- Mar 2021
- First submitted
- 2 Aug 2017
- Last updated
- 24 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03241342
- Acronym / sponsor ID
- ASTRID / G201002
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1 mg GTx-024 | Active comparator | Drug: GTx 024Study 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. |
| 3 mg GTx-024 | Active comparator | Drug: GTx 024Study 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. |
| matching placebo | Placebo comparator | Drug: PlaceboStudy 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTx 024Also: EnobosarmStudy drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. | Drug | 1 mg GTx-024, 3 mg GTx-024 |
| PlaceboPlacebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024. | Drug | matching placebo |
Primary outcome
Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12
Time frame: 12 Weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Peters, MD principal investigator
Oakland University, William Beaumont School of Medicine
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTx 024 in people with Stress Urinary Incontinence, run by GTx at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a ≥ 50% Reduction From Baseline in the Mean Number of Stress Incontinence Episodes Per Day at Week 12 (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.