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

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

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

This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.

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