Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women
NCT01833663 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2014-03-20
Summary
This study is a multi-site, randomized, opened and parallel-controlled clinical study.
The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.
Conditions
- Overactive Bladder
- Postmenopausal Disorder
- Urination Disorders
Interventions
- DRUG
-
Solifenacin Succinate Tablets
- DRUG
Sponsors & Collaborators
-
Astellas Pharma China, Inc.
collaborator INDUSTRY -
Beijing CAT Science Co., Ltd.
collaborator UNKNOWN -
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Lan Zhu, doctor · Peking Union Medical College Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2013-10-31
- Completion
- 2013-10-31
Countries
- China
Study Locations
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