Duloxetine Stress Urinary Incontinence Efficacy and Safety Study
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|ClinicalTrials.gov Identifier: NCT00475397|
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Drug: Duloxetine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With Stress Urinary Incontinence|
|Study Start Date :||December 2003|
|Actual Study Completion Date :||October 2004|
- To assess the efficacy of duloxetine 80 mg/day for 8 weeks in women with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.
- (Note: For the purposes of this study, SUI is defined as incontinence occurring with effort or exertion or on sneezing or coughing (Abrams et al. 2002).)
- To compare the efficacy of duloxetine with that of placebo as measured by the change in the disease-specific quality of life instrument (I QOL) scores from baseline to endpoint.
- To compare the efficacy of duloxetine with that of placebo in subject perceived improvement in SUI as measured by the Patient’s Global Impressions of Improvement (PGI I) questionnaire.
- To compare the safety of duloxetine with that of placebo in the treatment of SUI based on vital signs, laboratory values, and the occurrence of treatment-emergent adverse events (TEAEs).
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): NCT00475397
|Korea, Republic of|
|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.|
|Seoul, Korea, Republic of|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|