NCT05674045已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- the percent change in the urinary incontinence volume measured in a 1-hour pad test
研究概览
简要总结
The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo Comparator: matching placebo
Placebo Comparator
干预措施: EG017 3mg (Drug)
EG017 3mg
Experimental
干预措施: EG017 3mg (Drug)
EG017 6mg
Experimental
干预措施: EG017 6mg (Drug)
EG017 9mg
Experimental
干预措施: EG017 3mg (Drug)
EG017 9mg
Experimental
干预措施: EG017 6mg (Drug)
Placebo Comparator: matching placebo
Placebo Comparator
干预措施: EG017 6mg (Drug)
结局指标
主要结局
the percent change in the urinary incontinence volume measured in a 1-hour pad test
时间窗: Baseline, week 12
次要结局
- 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)
研究者
研究点 (1)
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