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



Status:Terminated
Conditions:Urology, Urology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:10/3/2018
Start Date:May 28, 2018
End Date:September 21, 2018

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

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.


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
We found this trial at
46
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Homewood, Alabama
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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Allentown, Pennsylvania 18103
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Anchorage, Alaska 99508
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Austin, Texas 78758
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Aventura, Florida 33180
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1 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
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Boston, Massachusetts 02135
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Boston, MA
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Charlotte, North Carolina 28207
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Cincinnati, Ohio 45212
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Clearwater, Florida 33761
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Columbus, Ohio 43213
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Dallas, Texas 75231
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DeLand, FL
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Denver, Colorado 80220
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10 Parsonage Road
Edison, New Jersey 08837
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Edison, NJ
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Englewood, Colorado
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Farmington, Connecticut 06032
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Garden City, New York 11530
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7580 Buckingham Boulevard
Hanover, Maryland 21076
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Idaho Falls, Idaho 83404
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Jackson, Tennessee 38301
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Jeffersonville, Indiana 47130
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Kalamazoo, Michigan 49009
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Las Vegas, Nevada 89148
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Lawrenceville, New Jersey 08648
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Layton, UT
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Lincoln, Nebraska 68510
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Meridian, Idaho 83642
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Miami, Florida 33186
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Mobile, Alabama 36608
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Mount Laurel, New Jersey 08054
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Mount Pleasant, South Carolina 29464
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801 McCarthy Boulevard
New Bern, North Carolina 28562
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3525 Prytania Street
New Orleans, Louisiana 70115
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New York, New York 10016
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Philadelphia, Pennsylvania 19104
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Pompano Beach, Florida 33060
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31157 Woodward Avenue
Royal Oak, Michigan 48073
Phone: 248-551-3551
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San Antonio, Texas 78229
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Sandy Springs, Georgia 30328
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3216 Northeast 45th Place
Seattle, Washington 98105
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Shreveport, Louisiana 71106
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Watertown, Massachusetts 02472
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West Des Moines, Iowa 50266
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599 Delaware Avenue
West Seneca, New York 14224
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West Seneca, NY
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