A Study of TAS-303 in Female Patients With Stress Urinary Incontinence

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Criteria

Key Inclusion Criteria:

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

• Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening

• Patient is positive in 1-hour pad weight test at screening

• Patient has at least 2 incontinence episodes per week.

Key Exclusion Criteria:

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

• Patient had a prior surgical SUI treatment

• Patient is diagnosed Pelvic Organ Prolapse

• Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.

• Patient is positive pregnancy test