NCT05674045

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DRUG	EG017 3mg	EG017 3mg/day Oral administration for 12 weeks, once daily
DRUG	EG017 6mg	EG017 6mg/day Oral administration for 12 weeks, once daily

Timeline

• Start date: 2022-01-06
• Primary completion: 2022-01-06
• Completion: 2022-09-26
• First posted: 2023-01-06
• Last updated: 2023-01-06

Locations

1 site across 1 country: China