[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase IIb clinical study to evaluate the efficacy and safety of oral administration of EG017 tablets in postmenopausal middle-aged and elderly women with stress urinary incontinence
主要目的 以安慰剂为对照,评价EG017片治疗绝经后中老年女性压力性尿失禁(SUI)的有效性。 次要目的 适用于治疗期:1.以安慰剂为对照,在多个疗效评估时间点,以(除主要研究终点外的)其他多个疗效评价指标,评价EG017片治疗绝经后的中老年女性SUI的疗效;2.评估EG017片在绝经后中老年女性SUI患者中的药代动力学(PK);3.评估EG017片用于绝经后中老年女性SUI患者治疗的安全性
[Translation] Primary objective: To evaluate the effectiveness of EG017 tablets in the treatment of stress urinary incontinence (SUI) in postmenopausal middle-aged and elderly women, using placebo as a control. Secondary objectives: Applicable to the treatment period: 1. Using placebo as a control, at multiple efficacy evaluation time points, and using multiple efficacy evaluation indicators (except the primary study endpoint), to evaluate the efficacy of EG017 tablets in the treatment of SUI in postmenopausal middle-aged and elderly women; 2. To evaluate the pharmacokinetics (PK) of EG017 tablets in postmenopausal middle-aged and elderly women with SUI; 3. To evaluate the safety of EG017 tablets in the treatment of postmenopausal middle-aged and elderly women with SUI.