Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
Brief summary
The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.
Detailed description
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.
Interventions
DRUGTAS-303 18mg single-dose
DRUGPlacebo 18mg single-dose
DRUGTAS-303 9mg single-dose
DRUGPlacebo 9mg single-dose
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Maximum Urethral Closure Pressure (MUCP) | Baseline, 6 hours after the administration |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by incidence and severity of adverse events | Up to 36 days after the administration |
| Maximum plasma concentration (Cmax) of TAS-303 | 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration |
| Urethral pressure profile parameters: mean urethral closure pressure, functional profile length | Baseline, 6 hours after the administration |
| Area under the plasma concentration versus time curve (AUC) of TAS-303 | Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration |
| Elimination half-time (t1/2) of TAS-303 | 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration |
| Time to maximum plasma concentration (tmax) of TAS-303 | 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration |
Countries
Japan
Outcome results
None listed