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Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

Phase 3
Completed
Conditions
Urinary Incontinence Stress
Registration Number
NCT00191204
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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
363
Inclusion Criteria
  • Female out patients
  • Are ambulatory and are able to use a toilet independently and without difficulty.
Exclusion Criteria
  • Use of monoamine oxidase inhibitors (MAOIs)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.
Secondary Outcome Measures
NameTimeMethod
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.

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.

🇬🇧

Peterborough, United Kingdom

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
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