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NCT03241342 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
A Phase 2 study of Stress Urinary Incontinence, sponsored by GTx.
- Completed
- Registry status
- Phase 2
- Development phase
- 491
- Enrollment target
- 20
- Study locations
NCT03241342 is a Phase 2 study of Stress Urinary Incontinence that has completed, run by GTx. The registered enrollment target is 491 participants, above the 149-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (230% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT03241342, a Phase 2 study of Stress Urinary Incontinence, has completed, sponsored by GTx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 491 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG GTx 024
Study Locations (20)
Florida
- South Florida Medical Research - Aventura
- Tampa Bay Medical Research Inc - Clearwater
- Midland Florida Clinical Research Center LLC - DeLand
- Precision Clinical Research - Lauderdale Lakes
- Lone Star Research Center - Miami
- Medical Research of Florida - Miami
- Clinical Research Center of Florida - Pompano Beach
Connecticut
- Women's Health Specialty Care - Farmington
- Coastal Connecticut Research, LLC - New London
- Bladder Control Center of Connecticut - Norwalk
Alabama
- Urology Center of Alabama - Homewood
- Coastal Clinical Research Inc - Mobile
Arizona
- Mayo Clinic Arizona - Phoenix
- Urological Associates of Southern Arizona - Tucson
California
- Women's Healthcare Research Corporation - San Diego
- American Institute of Research - Whittier
Colorado
- Genitourinary Surgical Consultants - Denver
- Urology Associates Research - Englewood
Alaska
- Alaska Clinical Research Center - Anchorage
District of Columbia
- James A Simon MD PC - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 491 participants |
| Start Date | 2017-08-21 |
| Est. Completion | 2018-09-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03241342
The ClinicalTrials.gov registry entry for NCT03241342 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 491 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 149-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (230% higher). The listed sponsor is GTx, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03241342 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Connecticut, Alabama.
Frequently Asked Questions
What is clinical trial NCT03241342 about?
NCT03241342 is a clinical study titled "Study to Assess 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 inc...
What is the current status of trial NCT03241342?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 491 participants. The study started on 2017-08-21. Estimated completion is 2018-09-21.
What conditions does trial NCT03241342 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT03241342?
The interventions under investigation include: Placebo (DRUG), GTx 024 (DRUG).
Who is sponsoring clinical trial NCT03241342?
This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03241342 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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