This open-label extension study, for subjects from the G201002 study, will provide additional long-term safety and tolerability data for GTx-024. All subjects in this study will receive GTx-024 3 mg orally, once daily.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. Subjects will be required to take one 3 mg Softgel capsule per day.
Safety of GTx-024, adverse events
Change from baseline in incidence of adverse events
Time frame: baseline through study completion, an average of 1 year
Safety of GTx-024, liver function test
Change from baseline in liver function test
Time frame: baseline through study completion, an average of 1 year
Safety of GTx-024, lipid panel
Change from baseline in lipid panel
Time frame: baseline through study completion, an average of 1 year
Safety of GTx-024, sex-hormone binding globulin levels
Change from baseline in sex-hormone binding globulin levels
Time frame: baseline through study completion, an average of 1 year
Safety of GTx-024, testosterone levels
Change from baseline in testosterone levels
Time frame: baseline through study completion, an average of 1 year
Safety of GTx-024, endometrial stripe thickness
Change from baseline in endometrial stripe thickness as measured by transvaginal ultrasound
Time frame: baseline through study completion, an average of 1 year
Safety of GTx-024, weight
Change from baseline weight
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, stress incontinence
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Urology Center of Alabama
Homewood, Alabama, United States
Coastal Clinical Research Inc
Mobile, Alabama, United States
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Anchorage, Alaska, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
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Englewood, Colorado, United States
Women's Health Specialty Care
Farmington, Connecticut, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
So. Florida Medical Research
Aventura, Florida, United States
Tampa Bay Medical Research Inc
Clearwater, Florida, United States
Midland Florida Clinical Research Center LLC
DeLand, Florida, United States
...and 36 more locations
Change from baseline in the mean number of stress incontinence episodes per day
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of severity
Change in patient global impression of severity (PGI-S; scale: 1-normal, 2-mild, 3-moderate, 4-severe; representing severity of urinary tract dysfunction)
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, patient global impression of improvement
Change in patient global impression of improvement (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 through study completion, an average of 1 year
Efficacy of GTx-024, urge incontinence
Change from baseline in the mean number of urge incontinence episodes per day
Time frame: baseline through study completion, an average of 1 year
Efficacy of GTx-024, total incontinence
Change from baseline in the mean number of total (stress + urge) incontinence episodes per day
Time frame: baseline through study completion, an average of 1 year