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

• Sponsor: GeneScience Pharmaceuticals Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05674045
• Collaborator: Peking University People's Hospital (Other)
• Enrollment: 51
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: EG017 3mg; Drug: EG017 6mg	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 6, 2022
• Actual Primary Completion Date: Jan 6, 2022
• Actual Study Completion Date: Sep 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EG017 3mg	Drug: EG017 3mg; EG017 3mg/day Oral administration for 12 weeks, once daily
Experimental: EG017 6mg	Drug: EG017 6mg; EG017 6mg/day Oral administration for 12 weeks, once daily
Experimental: EG017 9mg	Drug: EG017 3mg; EG017 3mg/day Oral administration for 12 weeks, once daily; Drug: EG017 6mg; EG017 6mg/day Oral administration for 12 weeks, once daily
Placebo Comparator: Placebo Comparator: matching placebo	Drug: EG017 3mg; EG017 3mg/day Oral administration for 12 weeks, once daily; Drug: EG017 6mg; EG017 6mg/day Oral administration for 12 weeks, once daily

Outcome Measures

Primary Outcome Measures

1. the percent change in the urinary incontinence volume measured in a 1-hour pad test [Baseline, week 12]

Secondary Outcome Measures

1. The percent change in urinary incontinence volume measured in a 24-hour pad test [Baseline, week 12]

2. The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test [Baseline, week 8 week20]

3. The average urinary incontinence episode frequency per 24 hours [Baseline, week 8, week 12, week20]

4. The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) [Baseline, week 8, week 12,week20]

5. The change in UDI-6 scores [Baseline, week 8, week 12,week20]

6. The change in PISQ-6 scores [Baseline, week 8, week 12,week20]

7. Incidence of adverse events and side effects [Up to 20 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	People's Hospital of Peking University	Beijing	Beijing	China	100000

Sponsors and Collaborators

• GeneScience Pharmaceuticals Co., Ltd.
• Peking University People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05674045
• Other Study ID Numbers: GenSci1002021II
• First Posted: Jan 6, 2023
• Last Update Posted: Jan 6, 2023
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GeneScience Pharmaceuticals Co., Ltd.: stress urinary incontinence; Selective Androgen Receptor Modulator (SARM)
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

No Results Posted as of Jan 6, 2023