Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00191204|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Stress||Drug: Duloxetine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||363 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence|
|Study Start Date :||September 2001|
|Estimated Study Completion Date :||May 2006|
- The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.
- The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191204
|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.|
|Peterborough, United Kingdom, PE3 6JG|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 Mon - Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|