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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
Durability of Response, stress incontinence
Change from G201002 baseline in the mean number of stress incontinence episodes per day
Time frame: baseline to 20 weeks
Durability of Response, patient global impression of severity
Change from G201002 baseline in patient global impression of severity scale (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)
Time frame: baseline to 20 weeks
Durability of Response, patient global impression of improvement
Change from G201002 baseline in patient global impression of improvement scale (PGI-I; scale: 1-very much better, 2-much better, 3-a little better, 4-no change, 5-a little worse, 6-much worse, 7-very much worse; representing change in urinary tract dysfunction from initiation of therapy)
Time frame: baseline to 20 weeks
Durability of Response, urge incontinence
Change from G201002 baseline in the mean number of urge incontinence episodes per day
Time frame: baseline to 20 weeks
Durability of Response, total incontinence
Change from G201002 baseline in the mean number of total (stress + urge) incontinence episodes per day
Time frame: baseline to 20 weeks
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