Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2, Open-Label Extension Study to Assess Long-Term Safety and Tolerability of Enobosarm (GTx 024) in Postmenopausal Women With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: GTx-024


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be an eligible subject from G201002, where an eligible subject is defined as: one of the first 225 subjects who were randomly assigned to the placebo group in G201002 and who have completed the required treatment and durability periods of that study, or; any subject from 226 onwards, who was randomly assigned to any treatment group and who completed the required treatment and follow-up periods of that study Be able to read, understand, and provide written, dated, informed consent prior to enrollment in the current study and be likely to comply with the study protocol and communicate with study personnel about AEs and other clinically important information Provide written consent to participate in the study within the following timeframes: for G201002 Subjects 1-225, within 30 days after unblinding of G201002 (subjects who consent to participate in G201003 will be allowed to discontinue from that study and consent to this study upon unblinding of G201002) for G201002 Subjects 226-493, within 30 days of completing both the treatment and follow-up periods of G201002 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 Subject is currently taking systemic sex-hormone products (excludes intravaginal application of estradiol topical/tablet agents and hormones delivered via vaginal rings) Has a current cancer diagnosis (with the exception of nonmelanoma skin cancer) or any history of breast or endometrial cancer Has a known history or current episode of: New York Heart Association Stage ≥ 2 hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) at screening and/or baseline. Subjects with hypertension that has been treated and controlled with medication for ≥ 2 weeks prior to screening are eligible for participation Recent myocardial infarction or arterial or venous thromboembolic event (within 1 year) or a history of more than 1 myocardial infarction or arterial or venous thromboembolic event Cardiac-related syncopal event within the past year Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass surgery, angioplasty). For subjects with previous stent placement, please contact the medical monitor Congestive heart failure of Stage > 2 according to New York Heart Association criteria Angina pectoris Has a current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk, impact the absorption of the study drug, or interfere with interpretation of study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Extension, 3 mg GTx-024<br>Eligible subjects from G201002 | Drug: GTx-024<br>* 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.<br>* Other names: enobosarm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of GTx-024, adverse events | Change from baseline in incidence of adverse events | baseline through study completion, an average of 1 year | 
| Safety of GTx-024, liver function test | Change from baseline in liver function test | baseline through study completion, an average of 1 year | 
| Safety of GTx-024, lipid panel | Change from baseline in lipid panel | 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 | baseline through study completion, an average of 1 year | 
| Safety of GTx-024, testosterone levels | Change from baseline in testosterone levels | 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 | baseline through study completion, an average of 1 year | 
| Safety of GTx-024, weight | Change from baseline weight | baseline through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of GTx-024, stress incontinence | Change from baseline in the mean number of stress incontinence episodes per day | 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) | 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) | 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 | 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 | baseline through study completion, an average of 1 year |