Clinical trial NCT03508648: Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
Official title: Phase 2 Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Lead sponsor: GTx
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 α-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

Primary outcomes:
measure: Durability of Response, stress incontinence
timeFrame: baseline to 20 weeks
measure: Durability of Response, patient global impression of severity
timeFrame: baseline to 20 weeks
measure: Durability of Response, patient global impression of improvement
timeFrame: baseline to 20 weeks
Secondary outcomes:
measure: Durability of Response, urge incontinence
timeFrame: baseline to 20 weeks
measure: Durability of Response, total incontinence
timeFrame: baseline to 20 weeks
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Center of Alabama
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Denver
country: United States
facility: Genitourinary Surgical Consultants
state: Colorado
city: Englewood
country: United States
facility: Urology Associates Research
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center LLC
state: Florida
city: Miami
country: United States
facility: Medical Research of Florida
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institue
state: Idaho
city: Jeffersonville
country: United States
facility: First Urology PSC
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Clinic
state: Iowa
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Hanover
country: United States
facility: Chesapeake Urology Associates PA
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials
state: Massachusetts
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital Urology Research
state: Michigan
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon J Freedman MD Ltd
state: Nevada
city: Edison
country: United States
facility: Premier Urology Group, LL
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence Obs Gyn clinical Research
state: New Jersey
city: Mount Laurel
country: United States
facility: Delaware Valley Urology
state: New Jersey
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: New York
country: United States
facility: Manhattan Medical Research Practice PLLC
state: New York
city: West Seneca
country: United States
facility: Circuit Clinical
state: New York
city: Charlotte
country: United States
facility: American Health Research Inc
state: North Carolina
city: New Bern
country: United States
facility: Eastern Carolina Women's
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern PA LLP
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Austin
country: United States
facility: Elligo - Austin Area OBGYN
state: Texas
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research PA
state: Texas
city: Layton
country: United States
facility: Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
state: Utah
city: Seattle
country: United States
facility: Seattle Womens: Health, Research, Gynocology
state: Washington
Study officials:
affiliation: Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: