To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence
- Conditions
- Stress Urinary Incontinence
- Registration Number
- NCT00190632
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 600
Have had symptoms of SUI for at least 3 months prior to study entry.
Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).
Ambulatory and able to use a toilet independently and without difficulty.
Subjects who participated or were discontinued from any previous studies investigating duloxetine.
Use of excluded medications within 14 days prior to study entry or at any time during the study.
Subjects who currently have or have had a history of urogenital cancer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
- Secondary Outcome Measures
Name Time Method To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
🇺🇸Cleveland, Ohio, United States