Duloxetine in the Treatment of Stress Urinary Incontinence.

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00191087
• Collaborator: Boehringer Ingelheim (Industry)
• Enrollment: 458
• Location: 1
• Duration (Months): 61
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Stress	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: Apr 1, 2001
• Study Completion Date: May 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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 to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women with predominant stress urinary incontinence.

• 7 or more incontinence episodes per week.

Exclusion Criteria:

• Use of monoamine inhibitors.

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 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.	London	England	United Kingdom	SE3 7UQ

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00191087
• Other Study ID Numbers: 2686; F1J-MC-SBAU
• First Posted: Sep 19, 2005
• Last Update Posted: Jan 26, 2007
• Last Verified: Jan 1, 2007

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Duloxetine Hydrochloride

Study Results

No Results Posted as of Jan 26, 2007