Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03508648

Run by

GTx

People needed

0

Starts

2018-05-28

Expected to finish

2018-09-21

Last updated by the study team

2023-09-14

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be one of the first 225 subjects who were randomly assigned to treatment in G201002 (Phase 2 study) and have completed the 12-week treatment and 16-week durability periods
• Be able to read, understand, and provide written, dated informed consent prior to enrollment in the current study (within 2 weeks of completing G201002) and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
• Agree to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the study

You may not qualify if…

• Starts any new treatment (medication, pelvic floor physical therapy, or other treatment known to impact the pelvic floor) after completing G201002 that is known or suspected to affect lower urinary tract function, including vaginal rejuvenation
• Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with interpretation of study results

Where it is running

• Urology Center of Alabama — Homewood, Alabama, United States
• Coastal Clinical Research Inc — Mobile, Alabama, United States
• Alaska Clinical Research Center — Anchorage, Alaska, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• Urology Associates Research — Englewood, Colorado, United States
• Women's Health Specialty Care — Farmington, Connecticut, United States
• Coastal Connecticut Research, LLC — New London, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Tampa Bay Medical Research Inc — Clearwater, Florida, United States
• Midland Florida Clinical Research Center LLC — DeLand, Florida, United States
• Medical Research of Florida — Miami, Florida, United States
• Clinical Research Center of Florida — Pompano Beach, Florida, United States
• Mount Vernon Clinical Research LLC — Sandy Springs, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Idaho Urologic Institue — Meridian, Idaho, United States
• First Urology PSC — Jeffersonville, Indiana, United States
• Iowa Clinic — West Des Moines, Iowa, United States
• DelRicht Clinical Research, LLC — New Orleans, Louisiana, United States
• Regional Urology — Shreveport, Louisiana, United States
• Chesapeake Urology Associates PA — Hanover, Maryland, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Bay State Clinical Trials — Watertown, Massachusetts, United States
• Beyer Research — Kalamazoo, Michigan, United States
• William Beaumont Hospital Urology Research — Royal Oak, Michigan, United States
• Women's Clinic of Lincoln — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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