Back to resultsDurability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GTx-024
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
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
Sites / Locations
- Urology Center of Alabama
- Coastal Clinical Research Inc
- Alaska Clinical Research Center
- Genitourinary Surgical Consultants
- Urology Associates Research
- Women's Health Specialty Care
- Coastal Connecticut Research, LLC
- South Florida Medical Research
- Tampa Bay Medical Research Inc
- Midland Florida Clinical Research Center LLC
- Medical Research of Florida
- Clinical Research Center of Florida
- Mount Vernon Clinical Research LLC
- Clinical Research Prime
- Idaho Urologic Institue
- First Urology PSC
- Iowa Clinic
- DelRicht Clinical Research, LLC
- Regional Urology
- Chesapeake Urology Associates PA
- Boston Clinical Trials
- Bay State Clinical Trials
- Beyer Research
- William Beaumont Hospital Urology Research
- Women's Clinic of Lincoln
- Sheldon J Freedman MD Ltd
- Premier Urology Group, LL
- Lawrence Obs Gyn clinical Research
- Delaware Valley Urology
- Accumed Research Associates
- Manhattan Medical Research Practice PLLC
- Circuit Clinical
- American Health Research Inc
- Eastern Carolina Women's
- The Urology Group
- Aventiv Research
- Institute for Female Pelvic Medicine
- Urologic Consultants of Southeastern PA LLP
- University of Pennsylvania Health System
- Coastal Carolina Research Center
- The Jackson Clinic
- Elligo - Austin Area OBGYN
- Urology Clinics of North Texas
- Urology San Antonio Research PA
- Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
- Seattle Womens: Health, Research, Gynocology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Matching Placebo
1 mg GTx-024
3 mg GTx-024
Arm Description
Subjects previously enrolled in the placebo arm of study G201002.
Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.
Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.
Outcomes
Primary Outcome Measures
Durability of Response, stress incontinence
Change from G201002 baseline in the mean number of stress incontinence episodes per day
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)
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)
Secondary Outcome Measures
Durability of Response, urge incontinence
Change from G201002 baseline in the mean number of urge incontinence episodes per day
Durability of Response, total incontinence
Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03508648
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of efficacy from primary study
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
September 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GTx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects previously enrolled in the placebo arm of study G201002.
Arm Title
1 mg GTx-024
Arm Type
Active Comparator
Arm Description
Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002.
Arm Title
3 mg GTx-024
Arm Type
Active Comparator
Arm Description
Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002.
Intervention Type
Drug
Intervention Name(s)
GTx-024
Other Intervention Name(s)
enobosarm
Intervention Description
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Primary Outcome Measure Information:
Title
Durability of Response, stress incontinence
Description
Change from G201002 baseline in the mean number of stress incontinence episodes per day
Time Frame
baseline to 20 weeks
Title
Durability of Response, patient global impression of severity
Description
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)
Time Frame
baseline to 20 weeks
Title
Durability of Response, patient global impression of improvement
Description
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)
Time Frame
baseline to 20 weeks
Secondary Outcome Measure Information:
Title
Durability of Response, urge incontinence
Description
Change from G201002 baseline in the mean number of urge incontinence episodes per day
Time Frame
baseline to 20 weeks
Title
Durability of Response, total incontinence
Description
Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day
Time Frame
baseline to 20 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Center of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Coastal Clinical Research Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Genitourinary Surgical Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Urology Associates Research
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Women's Health Specialty Care
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Tampa Bay Medical Research Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Midland Florida Clinical Research Center LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Medical Research of Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Mount Vernon Clinical Research LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Idaho Urologic Institue
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
First Urology PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Iowa Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
DelRicht Clinical Research, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Regional Urology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Associates PA
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Bay State Clinical Trials
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
William Beaumont Hospital Urology Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Women's Clinic of Lincoln
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Sheldon J Freedman MD Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Premier Urology Group, LL
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Lawrence Obs Gyn clinical Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Delaware Valley Urology
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Accumed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Circuit Clinical
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
American Health Research Inc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Eastern Carolina Women's
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Aventiv Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Institute for Female Pelvic Medicine
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urologic Consultants of Southeastern PA LLP
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Elligo - Austin Area OBGYN
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology San Antonio Research PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Seattle Womens: Health, Research, Gynocology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
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