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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2022-09-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder

NCT00321477

Incontinence, Urinary and Urinary Bladder, Overactive Overactive Bladder

COMPLETED PHASE2

A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)

NCT00231790

Urinary Incontinence

COMPLETED PHASE2

A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder

NCT03566134

Overactive Bladder

COMPLETED PHASE2

Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence

NCT00190567

Urinary Stress Incontinence

COMPLETED PHASE2

Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

NCT00196404

Urinary Incontinence

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EG017 3mg

Group Type EXPERIMENTAL

EG017 3mg

Intervention Type DRUG

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

EG017 6mg

Group Type EXPERIMENTAL

EG017 6mg

Intervention Type DRUG

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

EG017 9mg

Group Type EXPERIMENTAL

EG017 3mg

Intervention Type DRUG

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

EG017 6mg

Intervention Type DRUG

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

Placebo Comparator: matching placebo

Group Type PLACEBO_COMPARATOR

EG017 3mg

Intervention Type DRUG

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

EG017 6mg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EG017 3mg

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

Intervention Type DRUG

EG017 6mg

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No