Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Phase 2 Durability Extension Study to Assess Clinical Activity and Safety 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
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Matching Placebo<br>Subjects previously enrolled in the placebo arm of study G201002. | Drug: Matching Placebo<br>* Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.<br>|
| Active Comparator: 1 mg GTx-024<br>Subjects previously enrolled in the 1 mg GTx-024 arm of study G201002. | Drug: GTx-024<br>* Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.<br>* Other names: enobosarm;|
| Active Comparator: 3 mg GTx-024<br>Subjects previously enrolled in the 3 mg GTx-024 arm of study G201002. | Drug: GTx-024<br>* Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.<br>* Other names: enobosarm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of Response, stress incontinence | Change from G201002 baseline in the mean number of stress incontinence episodes per day | 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) | 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) | baseline to 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of Response, urge incontinence | Change from G201002 baseline in the mean number of urge incontinence episodes per day | 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 | baseline to 20 weeks |