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
sites
Columbus, Ohio 43213
8
mi
from 43215
Columbus, OH
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
579
mi
from 43215
New London, CT
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Allentown, Pennsylvania 18103
400
mi
from 43215
Allentown, PA
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Anchorage, Alaska 99508
3101
mi
from 43215
Anchorage, AK
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Austin, Texas 78758
1065
mi
from 43215
Austin, TX
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Aventura, Florida 33180
982
mi
from 43215
Aventura, FL
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1 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
413
mi
from 43215
Bala-Cynwyd, PA
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Boston, Massachusetts 02135
643
mi
from 43215
Boston, MA
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Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
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Cincinnati, Ohio 45212
94
mi
from 43215
Cincinnati, OH
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Clearwater, Florida 33761
824
mi
from 43215
Clearwater, FL
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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761
mi
from 43215
DeLand, FL
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Denver, Colorado 80220
1158
mi
from 43215
Denver, CO
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10 Parsonage Road
Edison, New Jersey 08837
459
mi
from 43215
Edison, NJ
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Englewood, Colorado
1163
mi
from 43215
Englewood, CO
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Farmington, Connecticut 06032
544
mi
from 43215
Farmington, CT
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Garden City, New York 11530
496
mi
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Garden City, NY
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7580 Buckingham Boulevard
Hanover, Maryland 21076
341
mi
from 43215
Hanover, MD
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Homewood, Alabama
494
mi
from 43215
Homewood, AL
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Idaho Falls, Idaho 83404
1507
mi
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Idaho Falls, ID
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Jackson, Tennessee 38301
436
mi
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Jackson, TN
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Jeffersonville, Indiana 47130
186
mi
from 43215
Jeffersonville, IN
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Kalamazoo, Michigan 49009
211
mi
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Kalamazoo, MI
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Las Vegas, Nevada 89148
1767
mi
from 43215
Las Vegas, NV
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Lawrenceville, New Jersey 08648
438
mi
from 43215
Lawrenceville, NJ
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1515
mi
from 43215
Layton, UT
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Lincoln, Nebraska 68510
719
mi
from 43215
Lincoln, NE
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Meridian, Idaho 83642
1725
mi
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Meridian, ID
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Miami, Florida 33186
999
mi
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Miami, FL
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Mobile, Alabama 36608
703
mi
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Mobile, AL
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Mount Laurel, New Jersey 08054
430
mi
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Mount Laurel, NJ
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Mount Pleasant, South Carolina 29464
523
mi
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Mount Pleasant, SC
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801 McCarthy Boulevard
New Bern, North Carolina 28562
466
mi
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New Bern, NC
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3525 Prytania Street
New Orleans, Louisiana 70115
800
mi
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New Orleans, LA
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New York, New York 10016
478
mi
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New York, NY
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Philadelphia, Pennsylvania 19104
414
mi
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Philadelphia, PA
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Pompano Beach, Florida 33060
963
mi
from 43215
Pompano Beach, FL
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31157 Woodward Avenue
Royal Oak, Michigan 48073
Phone: 248-551-3551
176
mi
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Royal Oak, MI
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San Antonio, Texas 78229
1138
mi
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San Antonio, TX
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Sandy Springs, Georgia 30328
423
mi
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Sandy Springs, GA
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3216 Northeast 45th Place
Seattle, Washington 98105
2005
mi
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Seattle, WA
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Shreveport, Louisiana 71106
791
mi
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Shreveport, LA
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Watertown, Massachusetts 02472
636
mi
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Watertown, MA
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West Des Moines, Iowa 50266
573
mi
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West Des Moines, IA
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599 Delaware Avenue
West Seneca, New York 14224
295
mi
from 43215
West Seneca, NY
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