Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence
Status:
Terminated
Trial end date:
2018-09-21
Target enrollment:
Participant gender:
Summary
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.