Duloxetine in the Treatment of Stress Urinary Incontinence.

Phase 3

Completed

• Conditions: Urinary Incontinence, Stress

• Registration Number: NCT00191087
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-05
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 458

Inclusion Criteria

• Women with predominant stress urinary incontinence.
• 7 or more incontinence episodes per week.

Exclusion Criteria

• Use of monoamine inhibitors.

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

Secondary Outcome Measures

Name	Time	Method
To collect data to demonstrate the maintenance of effect of duloxetine as measured by 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 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇬🇧 London, England, United Kingdom