Study Stopped
Lack of efficacy from primary study
Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
1 other identifier
interventional
N/A
1 country
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2018
Shorter than P25 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedStudy Start
First participant enrolled
May 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2018
CompletedSeptember 14, 2023
September 1, 2023
4 months
April 16, 2018
September 12, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Durability of Response, stress incontinence
Change from G201002 baseline in the mean number of stress incontinence episodes per day
baseline to 20 weeks
Durability of Response, patient global impression of severity
Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)
baseline to 20 weeks
Durability of Response, patient global impression of improvement
Change from G201002 baseline in patient global impression of improvement scale (PGI-I; scale: 1-very much better, 2-much better, 3-a little better, 4-no change, 5-a little worse, 6-much worse, 7-very much worse; representing change in urinary tract dysfunction from initiation of therapy)
baseline to 20 weeks
Secondary Outcomes (2)
Durability of Response, urge incontinence
baseline to 20 weeks
Durability of Response, total incontinence
baseline to 20 weeks
Study Arms (3)
Matching Placebo
PLACEBO COMPARATORSubjects previously enrolled in the placebo arm of study G201002.
1 mg GTx-024
ACTIVE COMPARATORSubjects previously enrolled in the 1 mg GTx-024 arm of study G201002.
3 mg GTx-024
ACTIVE COMPARATORSubjects previously enrolled in the 3 mg GTx-024 arm of study G201002.
Interventions
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GTxlead
Study Sites (46)
Urology Center of Alabama
Homewood, Alabama, 35209, United States
Coastal Clinical Research Inc
Mobile, Alabama, 36608, United States
Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Urology Associates Research
Englewood, Colorado, 80113, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Tampa Bay Medical Research Inc
Clearwater, Florida, 33761, United States
Midland Florida Clinical Research Center LLC
DeLand, Florida, 32720, United States
Medical Research of Florida
Miami, Florida, 33186, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Mount Vernon Clinical Research LLC
Sandy Springs, Georgia, 30328, United States
Clinical Research Prime
Idaho Falls, Idaho, 83221, United States
Idaho Urologic Institue
Meridian, Idaho, 83642, United States
First Urology PSC
Jeffersonville, Indiana, 47130, United States
Iowa Clinic
West Des Moines, Iowa, 50266, United States
DelRicht Clinical Research, LLC
New Orleans, Louisiana, 70115, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Associates PA
Hanover, Maryland, 21076, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Bay State Clinical Trials
Watertown, Massachusetts, 02472, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
William Beaumont Hospital Urology Research
Royal Oak, Michigan, 48073, United States
Women's Clinic of Lincoln
Lincoln, Nebraska, 68510, United States
Sheldon J Freedman MD Ltd
Las Vegas, Nevada, 89144, United States
Premier Urology Group, LL
Edison, New Jersey, 08837, United States
Lawrence Obs Gyn clinical Research
Lawrenceville, New Jersey, 08648, United States
Delaware Valley Urology
Mount Laurel, New Jersey, 08054, United States
Accumed Research Associates
Garden City, New York, 11530, United States
Manhattan Medical Research Practice PLLC
New York, New York, 10016, United States
Circuit Clinical
West Seneca, New York, 14224, United States
American Health Research Inc
Charlotte, North Carolina, 28207, United States
Eastern Carolina Women's
New Bern, North Carolina, 28562, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
Aventiv Research
Columbus, Ohio, 43213, United States
Institute for Female Pelvic Medicine
Allentown, Pennsylvania, 18103, United States
Urologic Consultants of Southeastern PA LLP
Bala-Cynwyd, Pennsylvania, 19004, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
The Jackson Clinic
Jackson, Tennessee, 38305, United States
Elligo - Austin Area OBGYN
Austin, Texas, 78758, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Urology San Antonio Research PA
San Antonio, Texas, 78229, United States
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
Layton, Utah, 84041, United States
Seattle Womens: Health, Research, Gynocology
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Peters, MD
Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2018
First Posted
April 26, 2018
Study Start
May 28, 2018
Primary Completion
September 21, 2018
Study Completion
September 21, 2018
Last Updated
September 14, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share