A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

Detailed Description
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The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-exploration Phase II Trial to Evaluate the Efficacy and Safety of EG017 Tablets in Postmenopausal Women With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: EG017 3mg
* Drug: EG017 6mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SUI symptoms of at least 6 months duration Urinary incontinence in the 1-hour pad test weight≥5g and<30 g Moderate to severe urinary incontinence evaluated by ICIQ-SF Exclusion Criteria: Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.) Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery before prior to study entry Patient has a serious illness or medical condition

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EG017 3mg<br> | Drug: EG017 3mg<br>* EG017 3mg/day Oral administration for 12 weeks, once daily<br>|
| Experimental: EG017 6mg<br> | Drug: EG017 6mg<br>* EG017 6mg/day Oral administration for 12 weeks, once daily<br>|
| Experimental: EG017 9mg<br> | Drug: EG017 3mg<br>* EG017 3mg/day Oral administration for 12 weeks, once daily<br>Drug: EG017 6mg<br>* EG017 6mg/day Oral administration for 12 weeks, once daily<br>|
| Placebo Comparator: Placebo Comparator: matching placebo<br> | Drug: EG017 3mg<br>* EG017 3mg/day Oral administration for 12 weeks, once daily<br>Drug: EG017 6mg<br>* EG017 6mg/day Oral administration for 12 weeks, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percent change in the urinary incontinence volume measured in a 1-hour pad test |  | Baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change in urinary incontinence volume measured in a 24-hour pad test |  | Baseline, week 12 | 
| The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test |  | Baseline, week 8 week20 | 
| The average urinary incontinence episode frequency per 24 hours |  | Baseline, week 8, week 12, week20 | 
| The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) |  | Baseline, week 8, week 12,week20 | 
| The change in UDI-6 scores |  | Baseline, week 8, week 12,week20 | 
| The change in PISQ-6 scores |  | Baseline, week 8, week 12,week20 | 
| Incidence of adverse events and side effects |  | Up to 20 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress urinary incontinence, Selective Androgen Receptor Modulator (SARM)