Skip to main content
OpenTrials
Completed

NCT Number: NCT05674045

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

The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

People's Hospital of Peking University

Beijing, Beijing Municipality, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EG017 3mg

Drug

EG017 3mg/day Oral administration for 12 weeks, once daily

EG017 6mg

Drug

EG017 6mg/day Oral administration for 12 weeks, once daily

Primary outcomes

  1. the percent change in the urinary incontinence volume measured in a 1-hour pad test

    Time frame: Baseline, week 12

Secondary outcomes

  1. The percent change in urinary incontinence volume measured in a 24-hour pad test

    Time frame: Baseline, week 12

  2. The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test

    Time frame: Baseline, week 8 week20

  3. The average urinary incontinence episode frequency per 24 hours

    Time frame: Baseline, week 8, week 12, week20

  4. The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

    Time frame: Baseline, week 8, week 12,week20

  5. The change in UDI-6 scores

    Time frame: Baseline, week 8, week 12,week20

  6. The change in PISQ-6 scores

    Time frame: Baseline, week 8, week 12,week20

  7. Incidence of adverse events and side effects

    Time frame: Up to 20 Weeks

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Peking University People's Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.