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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05674045

Enrollment

Registered

2023-01-06

Start date

2022-01-06

Completion date

2022-09-26

Last updated

2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, Selective Androgen Receptor Modulator (SARM)

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.

Interventions

DRUGEG017 3mg

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

DRUGEG017 6mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the percent change in the urinary incontinence volume measured in a 1-hour pad test	Baseline, week 12

Secondary

Measure	Time frame
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 percent change in urinary incontinence volume measured in a 24-hour pad test	Baseline, week 12
The change in PISQ-6 scores	Baseline, week 8, week 12,week20
Incidence of adverse events and side effects	Up to 20 Weeks
The change in UDI-6 scores	Baseline, week 8, week 12,week20

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026