Clinical trial NCT05674045: A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
Selective Androgen Receptor Modulator (SARM)
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University People's Hospital
First posted: 2023-01-06
Enrollment: 51
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: the percent change in the urinary incontinence volume measured in a 1-hour pad test
timeFrame: Baseline, week 12
Secondary outcomes:
measure: The percent change in urinary incontinence volume measured in a 24-hour pad test
timeFrame: Baseline, week 12
measure: The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
timeFrame: Baseline, week 8 week20
measure: The average urinary incontinence episode frequency per 24 hours
timeFrame: Baseline, week 8, week 12, week20
measure: The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
timeFrame: Baseline, week 8, week 12,week20
measure: The change in UDI-6 scores
timeFrame: Baseline, week 8, week 12,week20
measure: The change in PISQ-6 scores
timeFrame: Baseline, week 8, week 12,week20
measure: Incidence of adverse events and side effects
timeFrame: Up to 20 Weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
Study officials:
References: