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To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Phase 3
Completed
Conditions
Stress Urinary Incontinence
Registration Number
NCT00190645
Lead Sponsor
Eli Lilly and Company
Brief Summary

The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
600
Inclusion Criteria

Successfully completed the protocol for Study F1J-MC-SBAV.

Exclusion Criteria

Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI).
Secondary Outcome Measures
NameTimeMethod
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 (2)

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

🇺🇸

Denver, Colorado, United States

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

🇨🇦

Oakville, Ontario, Canada

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