Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence
- Registration Number
- NCT03566290
- Lead Sponsor
- GTx
- Brief Summary
This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
-
Be an eligible subject from G201002, where an eligible subject is defined as:
- 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;
- 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:
- 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)
- 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
-
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
-
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:
- 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
- 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
- Cardiac-related syncopal event within the past year
- Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor
- Congestive heart failure of Stage > 2 according to New York Heart Association criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-Label Extension, 3 mg GTx-024 GTx-024 Eligible subjects from G201002
- Primary Outcome Measures
Name Time Method Safety of GTx-024, lipid panel baseline through study completion, an average of 1 year Change from baseline in lipid panel
Safety of GTx-024, testosterone levels baseline through study completion, an average of 1 year Change from baseline in testosterone levels
Safety of GTx-024, endometrial stripe thickness baseline through study completion, an average of 1 year Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound
Safety of GTx-024, adverse events baseline through study completion, an average of 1 year Change from baseline in incidence of adverse events
Safety of GTx-024, liver function test baseline through study completion, an average of 1 year Change from baseline in liver function test
Safety of GTx-024, sex-hormone binding globulin levels baseline through study completion, an average of 1 year Change from baseline in sex-hormone binding globulin levels
Safety of GTx-024, weight baseline through study completion, an average of 1 year Change from baseline weight
- Secondary Outcome Measures
Name Time Method Efficacy of GTx-024, total incontinence baseline through study completion, an average of 1 year Change from baseline in the mean number of total (stress + urge) incontinence episodes per day
Efficacy of GTx-024, urge incontinence baseline through study completion, an average of 1 year Change from baseline in the mean number of urge incontinence episodes per day
Efficacy of GTx-024, patient global impression of improvement baseline through study completion, an average of 1 year Change in patient global impression of improvement (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)
Efficacy of GTx-024, stress incontinence baseline through study completion, an average of 1 year Change from baseline in the mean number of stress incontinence episodes per day
Efficacy of GTx-024, patient global impression of severity baseline through study completion, an average of 1 year Change in patient global impression of severity (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)
Trial Locations
- Locations (46)
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
William Beaumont Hospital Urology Research
🇺🇸Royal Oak, Michigan, United States
Aventiv Research
🇺🇸Columbus, Ohio, United States
Tampa Bay Medical Research Inc
🇺🇸Clearwater, Florida, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Womens: Health, Research, Gynocology
🇺🇸Seattle, Washington, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Premier Urology Group, LL
🇺🇸Edison, New Jersey, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Women's Clinic of Lincoln
🇺🇸Lincoln, Nebraska, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
Chesapeake Urology Associates PA
🇺🇸Hanover, Maryland, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Sheldon J Freedman MD Ltd
🇺🇸Las Vegas, Nevada, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
So. Florida Medical Research
🇺🇸Aventura, Florida, United States
Idaho Urologic Institue
🇺🇸Meridian, Idaho, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
Mount Vernon Clinical Research LLC
🇺🇸Sandy Springs, Georgia, United States
Genitourinary Surgical Consultants
🇺🇸Denver, Colorado, United States
Urology Center of Alabama
🇺🇸Homewood, Alabama, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Urology Associates Research
🇺🇸Englewood, Colorado, United States
Women's Health Specialty Care
🇺🇸Farmington, Connecticut, United States
Midland Florida Clinical Research Center LLC
🇺🇸DeLand, Florida, United States
Medical Research of Florida
🇺🇸Miami, Florida, United States
Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
First Urology PSC
🇺🇸Jeffersonville, Indiana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Lawrence Obs Gyn clinical Research
🇺🇸Lawrenceville, New Jersey, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
Accumed Research Associates
🇺🇸Garden City, 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
Urologic Consultants of Southeastern PA LLP
🇺🇸Bala-Cynwyd, Pennsylvania, 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
DelRicht Clinical Research, LLC
🇺🇸New Orleans, Louisiana, United States
Elligo - Austin Area OBGYN
🇺🇸Austin, Texas, United States
Bay State clinical Trials
🇺🇸Watertown, Massachusetts, United States