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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: EG017 3mg; Drug: EG017 6mg

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • People's Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EG017 3mg	Drug: EG017 3mg; EG017 3mg/day Oral administration for 12 weeks, once daily
Experimental: EG017 6mg	Drug: EG017 6mg; EG017 6mg/day Oral administration for 12 weeks, once daily
Experimental: EG017 9mg	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
Placebo Comparator: Placebo Comparator: matching placebo	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the percent change in the urinary incontinence volume measured in a 1-hour pad test	Baseline, week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Estimate): January 6, 2023

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: stress urinary incontinence; Selective Androgen Receptor Modulator (SARM)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: GenSci1002021II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No