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

NCT05674045 | Completed Phase 2

• 1 other identifier: GenSci1002021II
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; Selective Androgen Receptor Modulator (SARM)

Outcome Measures

Primary Outcomes (1)

• the percent change in the urinary incontinence volume measured in a 1-hour pad test

  Baseline, week 12

Secondary Outcomes (7)

• The percent change in urinary incontinence volume measured in a 24-hour pad test

  Baseline, week 12

• The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test

  Baseline, week 8 week20

• The average urinary incontinence episode frequency per 24 hours

  Baseline, week 8, week 12, week20

• The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

  Baseline, week 8, week 12,week20

• The change in UDI-6 scores

  Baseline, week 8, week 12,week20

Study Arms (4)

EG017 3mg

EXPERIMENTAL

Drug: EG017 3mg

EG017 6mg

EXPERIMENTAL

Drug: EG017 6mg

EG017 9mg

EXPERIMENTAL

Drug: EG017 3mg; Drug: EG017 6mg

Placebo Comparator: matching placebo

PLACEBO COMPARATOR

Drug: EG017 3mg; Drug: EG017 6mg

Interventions

EG017 3mg DRUG

EG017 3mg/day Oral administration for 12 weeks, once daily

EG017 3mg; EG017 9mg; Placebo Comparator: matching placebo

EG017 6mg DRUG

EG017 6mg/day Oral administration for 12 weeks, once daily

EG017 6mg; EG017 9mg; Placebo Comparator: matching placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Peking University People's Hospital: collaborator

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: January 6, 2022
• Primary Completion: January 6, 2022
• Study Completion: September 26, 2022
• Last Updated: January 6, 2023

Record last verified: 2022-10

Locations

CN (1)