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 |
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.
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
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1 Presidential Boulevard
Bala-Cynwyd, Pennsylvania 19004
Bala-Cynwyd, Pennsylvania 19004
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31157 Woodward Avenue
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Phone: 248-551-3551
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