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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674045
• Other study ID #: GenSci1002021II
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2022
• Est. completion date: September 26, 2022

Study information

• Verified date: October 2022
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 26, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• EG017 3mg
EG017 3mg/day Oral administration for 12 weeks, once daily
• EG017 6mg
EG017 6mg/day Oral administration for 12 weeks, once daily

Locations

Country	Name	City	State
China	People's Hospital of Peking University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percent change in the urinary incontinence volume measured in a 1-hour pad test		Baseline, week 12
Secondary	The percent change in urinary incontinence volume measured in a 24-hour pad test		Baseline, week 12
Secondary	The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test		Baseline, week 8 week20
Secondary	The average urinary incontinence episode frequency per 24 hours		Baseline, week 8, week 12, week20
Secondary	The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)		Baseline, week 8, week 12,week20
Secondary	The change in UDI-6 scores		Baseline, week 8, week 12,week20
Secondary	The change in PISQ-6 scores		Baseline, week 8, week 12,week20
Secondary	Incidence of adverse events and side effects		Up to 20 Weeks