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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Drug: EG017 6mg; Drug: EG017 3mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05674045

GenSci1002021II

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 4 patient groups, including a placebo group

EG017 3mg

Experimental group

Treatment:

Drug: EG017 3mg

EG017 6mg

Experimental group

Treatment:

Drug: EG017 6mg

EG017 9mg

Experimental group

Treatment:

Drug: EG017 6mg

Drug: EG017 3mg

Placebo Comparator: matching placebo

Placebo Comparator group

Treatment:

Drug: EG017 6mg

Drug: EG017 3mg