Back to resultsA Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
EG017 3mg
EG017 6mg
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, Selective Androgen Receptor Modulator (SARM)
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
Sites / Locations
- People's Hospital of Peking University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
EG017 3mg
EG017 6mg
EG017 9mg
Placebo Comparator: matching placebo
Arm Description
Outcomes
Primary Outcome Measures
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Secondary Outcome Measures
The percent change in urinary incontinence volume measured in a 24-hour pad test
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
The average urinary incontinence episode frequency per 24 hours
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
The change in UDI-6 scores
The change in PISQ-6 scores
Incidence of adverse events and side effects
Full Information
NCT ID
NCT05674045
First Posted
December 30, 2022
Last Updated
December 30, 2022
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05674045
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
September 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, Selective Androgen Receptor Modulator (SARM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EG017 3mg
Arm Type
Experimental
Arm Title
EG017 6mg
Arm Type
Experimental
Arm Title
EG017 9mg
Arm Type
Experimental
Arm Title
Placebo Comparator: matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EG017 3mg
Intervention Description
EG017 3mg/day Oral administration for 12 weeks, once daily
Intervention Type
Drug
Intervention Name(s)
EG017 6mg
Intervention Description
EG017 6mg/day Oral administration for 12 weeks, once daily
Primary Outcome Measure Information:
Title
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Time Frame
Baseline, week 12
Secondary Outcome Measure Information:
Title
The percent change in urinary incontinence volume measured in a 24-hour pad test
Time Frame
Baseline, week 12
Title
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
Time Frame
Baseline, week 8 week20
Title
The average urinary incontinence episode frequency per 24 hours
Time Frame
Baseline, week 8, week 12, week20
Title
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time Frame
Baseline, week 8, week 12,week20
Title
The change in UDI-6 scores
Time Frame
Baseline, week 8, week 12,week20
Title
The change in PISQ-6 scores
Time Frame
Baseline, week 8, week 12,week20
Title
Incidence of adverse events and side effects
Time Frame
Up to 20 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence
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