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

Stress Urinary Incontinence Clinical Trial

Official title:

Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03508648
• Other study ID #: G201003
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 28, 2018
• Est. completion date: September 21, 2018

Study information

• Verified date: September 2023
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 21, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 a-adrenergic blockers, throughout the duration of the study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• GTx-024
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
• Matching Placebo
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.

Locations

Country	Name	City	State
United States	Institute for Female Pelvic Medicine	Allentown	Pennsylvania
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	Elligo - Austin Area OBGYN	Austin	Texas
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Consultants of Southeastern PA LLP	Bala-Cynwyd	Pennsylvania
United States	Boston Clinical Trials	Boston	Massachusetts
United States	American Health Research Inc	Charlotte	North Carolina
United States	The Urology Group	Cincinnati	Ohio
United States	Tampa Bay Medical Research Inc	Clearwater	Florida
United States	Aventiv Research	Columbus	Ohio
United States	Urology Clinics of North Texas	Dallas	Texas
United States	Midland Florida Clinical Research Center LLC	DeLand	Florida
United States	Genitourinary Surgical Consultants	Denver	Colorado
United States	Premier Urology Group, LL	Edison	New Jersey
United States	Urology Associates Research	Englewood	Colorado
United States	Women's Health Specialty Care	Farmington	Connecticut
United States	Accumed Research Associates	Garden City	New York
United States	Chesapeake Urology Associates PA	Hanover	Maryland
United States	Urology Center of Alabama	Homewood	Alabama
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	The Jackson Clinic	Jackson	Tennessee
United States	First Urology PSC	Jeffersonville	Indiana
United States	Beyer Research	Kalamazoo	Michigan
United States	Sheldon J Freedman MD Ltd	Las Vegas	Nevada
United States	Lawrence Obs Gyn clinical Research	Lawrenceville	New Jersey
United States	Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice	Layton	Utah
United States	Women's Clinic of Lincoln	Lincoln	Nebraska
United States	Idaho Urologic Institue	Meridian	Idaho
United States	Medical Research of Florida	Miami	Florida
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	Delaware Valley Urology	Mount Laurel	New Jersey
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Eastern Carolina Women's	New Bern	North Carolina
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	DelRicht Clinical Research, LLC	New Orleans	Louisiana
United States	Manhattan Medical Research Practice PLLC	New York	New York
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	William Beaumont Hospital Urology Research	Royal Oak	Michigan
United States	Urology San Antonio Research PA	San Antonio	Texas
United States	Mount Vernon Clinical Research LLC	Sandy Springs	Georgia
United States	Seattle Womens: Health, Research, Gynocology	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	Bay State Clinical Trials	Watertown	Massachusetts
United States	Iowa Clinic	West Des Moines	Iowa
United States	Circuit Clinical	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durability of Response, stress incontinence	Change from G201002 baseline in the mean number of stress incontinence episodes per day	baseline to 20 weeks
Primary	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
Primary	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	Durability of Response, urge incontinence	Change from G201002 baseline in the mean number of urge incontinence episodes per day	baseline to 20 weeks
Secondary	Durability of Response, total incontinence	Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day	baseline to 20 weeks