Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry

• Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.

• Patient is positive in 1-hour pad weight test

Exclusion Criteria:

• Patient has predominant or primary urge incontinence according to investigator judgment

• Patient had a prior surgical SUI treatment

• Patient is diagnosed stageII or more of Pelvic Organ Prolapse

• Patient has symptoms of Urinary tract infection (UTI)

• Patient is positive pregnancy test

• Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.