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

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: EG017 3mg; Drug: EG017 6mg

• Registration Number: NCT05674045
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2022-01-06
• Primary Completion: 2022-01-06
• Study Completion: 2022-09-26
• Status Verified: 2022-10
• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2022-12-30
• Last Update Submitted: 2022-12-30
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EG017 3mg	EG017 3mg	-
EG017 6mg	EG017 6mg	-
EG017 9mg	EG017 3mg	-
EG017 9mg	EG017 6mg	-
Placebo Comparator: matching placebo	EG017 3mg	-
Placebo Comparator: matching placebo	EG017 6mg	-

Primary Outcome Measures

Name	Time	Method
the percent change in the urinary incontinence volume measured in a 1-hour pad test	Baseline, week 12

Secondary Outcome Measures

Name	Time	Method
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
Incidence of adverse events and side effects	Up to 20 Weeks
The change in PISQ-6 scores	Baseline, week 8, week 12,week20

Trial Locations

Locations (1)

People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China