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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | TAS-303 18mg single-dose and then Placebo single-dose. |
|
| Treatment B | Placebo Comparator | Placebo single-dose and then TAS-303 18mg single-dose. |
|
| Treatment C | Active Comparator | TAS-303 9mg single-dose and then Placebo single-dose. |
|
| Treatment D | Placebo Comparator | TAS-303 Placebo single-dose and then TAS-303 9mg single-dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-303 18mg single-dose | Drug |
| ||
| Placebo 18mg single-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Maximum Urethral Closure Pressure (MUCP) | Baseline, 6 hours after the administration |
| Measure | Description | Time Frame |
|---|---|---|
| Urethral pressure profile parameters: mean urethral closure pressure, functional profile length | Baseline, 6 hours after the administration | |
| Safety assessed by incidence and severity of adverse events | Up to 36 days after the administration |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd selected site | Kumamoto | Japan |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000718062 | TAS-303 |
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| Drug |
|
| TAS-303 9mg single-dose | Drug |
|
| Placebo 9mg single-dose | Drug |
|
| Maximum plasma concentration (Cmax) 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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |