Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
Public ClinicalTrials.gov record NCT03508648. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will enroll only from the first 225 subjects who were randomly assigned to treatment in G201002 (irrespective of the treatment allocation, i.e., GTx-024 or placebo) and who have completed the 12-week treatment period and 16-week durability period to assess the long-term durability of response to GTx-024 on SUI symptoms. The extension study will follow subjects for an additional 20 weeks to help better assess the durability of response in these subjects and will provide additional efficacy and safety data for the subjects. Subjects will not be provided with any study treatments and will be off-drug during this extension study.
Study identification
- NCT ID
- NCT03508648
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 27, 2018
- Primary completion
- Sep 20, 2018
- Completion
- Sep 20, 2018
- Last update posted
- Sep 13, 2023
2018
United States locations
- U.S. sites
- 46
- U.S. states
- 25
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Center of Alabama | Homewood | Alabama | 35209 | — |
| Coastal Clinical Research Inc | Mobile | Alabama | 36608 | — |
| Alaska Clinical Research Center | Anchorage | Alaska | 99503 | — |
| Genitourinary Surgical Consultants | Denver | Colorado | 80220 | — |
| Urology Associates Research | Englewood | Colorado | 80113 | — |
| Women's Health Specialty Care | Farmington | Connecticut | 06032 | — |
| Coastal Connecticut Research, LLC | New London | Connecticut | 06320 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| Tampa Bay Medical Research Inc | Clearwater | Florida | 33761 | — |
| Midland Florida Clinical Research Center LLC | DeLand | Florida | 32720 | — |
| Medical Research of Florida | Miami | Florida | 33186 | — |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | — |
| Mount Vernon Clinical Research LLC | Sandy Springs | Georgia | 30328 | — |
| Clinical Research Prime | Idaho Falls | Idaho | 83221 | — |
| Idaho Urologic Institue | Meridian | Idaho | 83642 | — |
| First Urology PSC | Jeffersonville | Indiana | 47130 | — |
| Iowa Clinic | West Des Moines | Iowa | 50266 | — |
| DelRicht Clinical Research, LLC | New Orleans | Louisiana | 70115 | — |
| Regional Urology | Shreveport | Louisiana | 71106 | — |
| Chesapeake Urology Associates PA | Hanover | Maryland | 21076 | — |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | — |
| Bay State Clinical Trials | Watertown | Massachusetts | 02472 | — |
| Beyer Research | Kalamazoo | Michigan | 49009 | — |
| William Beaumont Hospital Urology Research | Royal Oak | Michigan | 48073 | — |
| Women's Clinic of Lincoln | Lincoln | Nebraska | 68510 | — |
| Sheldon J Freedman MD Ltd | Las Vegas | Nevada | 89144 | — |
| Premier Urology Group, LL | Edison | New Jersey | 08837 | — |
| Lawrence Obs Gyn clinical Research | Lawrenceville | New Jersey | 08648 | — |
| Delaware Valley Urology | Mount Laurel | New Jersey | 08054 | — |
| Accumed Research Associates | Garden City | New York | 11530 | — |
| Manhattan Medical Research Practice PLLC | New York | New York | 10016 | — |
| Circuit Clinical | West Seneca | New York | 14224 | — |
| American Health Research Inc | Charlotte | North Carolina | 28207 | — |
| Eastern Carolina Women's | New Bern | North Carolina | 28562 | — |
| The Urology Group | Cincinnati | Ohio | 45212 | — |
| Aventiv Research | Columbus | Ohio | 43213 | — |
| Institute for Female Pelvic Medicine | Allentown | Pennsylvania | 18103 | — |
| Urologic Consultants of Southeastern PA LLP | Bala-Cynwyd | Pennsylvania | 19004 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| The Jackson Clinic | Jackson | Tennessee | 38305 | — |
| Elligo - Austin Area OBGYN | Austin | Texas | 78758 | — |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | — |
| Urology San Antonio Research PA | San Antonio | Texas | 78229 | — |
| Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice | Layton | Utah | 84041 | — |
| Seattle Womens: Health, Research, Gynocology | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03508648, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 13, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03508648 live on ClinicalTrials.gov.