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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190645

Collaborator

Boehringer Ingelheim (Industry)

600

Enrollment

Locations

62.9

Duration (Months)

300

Patients Per Site

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: Duloxetine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Study Start Date :

Feb 1, 2001

Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI). []

Secondary Outcome Measures

To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) questionnaire. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	Denver	Colorado	United States	80220
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	Oakville	Ontario	Canada	L6H3P1

Sponsors and Collaborators

Eli Lilly and Company
Boehringer Ingelheim

Investigators

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