NCT05674045
Completed
Phase 2
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
Changchun GeneScience Pharmaceutical Co., Ltd.1 site in 1 country51 target enrollmentJanuary 6, 2022
Overview
- Phase
- Phase 2
- Intervention
- EG017 3mg
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- the percent change in the urinary incontinence volume measured in a 1-hour pad test
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo Comparator: matching placebo
Intervention: EG017 3mg
EG017 3mg
Intervention: EG017 3mg
EG017 6mg
Intervention: EG017 6mg
EG017 9mg
Intervention: EG017 3mg
EG017 9mg
Intervention: EG017 6mg
Placebo Comparator: matching placebo
Intervention: EG017 6mg
Outcomes
Primary Outcomes
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Time Frame: Baseline, week 12
Secondary Outcomes
- 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)
Study Sites (1)
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