A Phase 2 interventional study of EG017 3mg and EG017 6mg in Stress Urinary Incontinence, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-01-06.
Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
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.
671 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.
This study's enrollment of 51 is below the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 48 are open to participants now.
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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
Drug: EG017 3mg
Drug: EG017 6mg
Drug: EG017 3mg · Drug: EG017 6mg
Drug: EG017 3mg · Drug: EG017 6mg
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Time frame: Baseline, week 12
The percent change in urinary incontinence volume measured in a 24-hour pad test
Time frame: Baseline, week 12
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
Time frame: Baseline, week 8 week20
The average urinary incontinence episode frequency per 24 hours
Time frame: Baseline, week 8, week 12, week20
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline, week 8, week 12,week20
The change in UDI-6 scores
Time frame: Baseline, week 8, week 12,week20
The change in PISQ-6 scores
Time frame: Baseline, week 8, week 12,week20
Incidence of adverse events and side effects
Time frame: Up to 20 Weeks
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: EG017
Urinary Incontinence, Stress →
Changchun GeneScience Pharmaceutical Co., Ltd. →