Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence
NCT ID: NCT03566290
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-06-28
2018-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-Label Extension, 3 mg GTx-024
Eligible subjects from G201002
GTx-024
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. Subjects will be required to take one 3 mg Softgel capsule per day.
Interventions
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GTx-024
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. Subjects will be required to take one 3 mg Softgel capsule per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. one of the first 225 subjects who were randomly assigned to the placebo group in G201002 and who have completed the required treatment and durability periods of that study, or;
2. any subject from 226 onwards, who was randomly assigned to any treatment group and who completed the required treatment and follow-up periods of that study
* Be able to read, understand, and provide written, dated, informed consent prior to enrollment in the current study and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information
* Provide written consent to participate in the study within the following timeframes:
1. for G201002 Subjects 1-225, within 30 days after unblinding of G201002 (subjects who consent to participate in G201003 will be allowed to discontinue from that study and consent to this study upon unblinding of G201002)
2. for G201002 Subjects 226-493, within 30 days of completing both the treatment and follow-up periods of G201002
* 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
* Subject is currently taking systemic sex-hormone products (excludes intravaginal application of estradiol topical/tablet agents and hormones delivered via vaginal rings)
* Has a current cancer diagnosis (with the exception of nonmelanoma skin cancer) or any history of breast or endometrial cancer
* Has a known history or current episode of:
1. New York Heart Association Stage ≥ 2 hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg) at screening and/or baseline. Subjects with hypertension that has been treated and controlled with medication for ≥ 2 weeks prior to screening are eligible for participation
2. Recent myocardial infarction or arterial or venous thromboembolic event (within 1 year) or a history of more than 1 myocardial infarction or arterial or venous thromboembolic event
3. Cardiac-related syncopal event within the past year
4. Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor
5. Congestive heart failure of Stage \> 2 according to New York Heart Association criteria
6. Angina pectoris
* Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk, impact the absorption of the study drug, or interfere with interpretation of study
18 Years
80 Years
FEMALE
No
Sponsors
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GTx
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Professor & Chair, Department of Urology, Oakland University Wm. Beaumont School of Medicine
Locations
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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
So. 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
Sheldon J Freedman MD Ltd
Las Vegas, Nevada, United States
Premier Urology Group, LL
Edison, New Jersey, United States
Lawrence Obs Gyn clinical Research
Lawrenceville, New Jersey, United States
Accumed Research Associates
Garden City, New York, United States
Manhattan Medical Research Practice PLLC
New York, New York, United States
Premier Medical Group
Poughkeepsie, New York, United States
Circuit Clinical
West Seneca, New York, United States
American Health Research Inc
Charlotte, North Carolina, United States
Eastern Carolina Women's
New Bern, North Carolina, United States
The Urology Group
Cincinnati, Ohio, United States
Aventiv Research
Columbus, Ohio, United States
Urologic Consultants of Southeastern PA LLP
Bala-Cynwyd, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
The Jackson Clinic
Jackson, Tennessee, United States
Elligo - Austin Area OBGYN
Austin, Texas, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Urology San Antonio Research PA
San Antonio, Texas, United States
Synexus Clinical Research Advantage, Inc. - Wasatch Peak Family Practice
Layton, Utah, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Seattle Womens: Health, Research, Gynocology
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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G201004
Identifier Type: -
Identifier Source: org_study_id
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