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

• Status: Completed
• Trial end date: 2022-09-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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