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

Use our guide to learn which trials are right for you!

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