Back to resultsDuloxetine in the Treatment of Stress Urinary Incontinence.
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress
Eligibility Criteria
Inclusion Criteria: Women with predominant stress urinary incontinence. 7 or more incontinence episodes per week. Exclusion Criteria: Use of monoamine inhibitors.
Sites / Locations
- 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.
Outcomes
Primary Outcome Measures
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence
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.
Full Information
NCT ID
NCT00191087
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00191087
Brief Title
Duloxetine in the Treatment of Stress Urinary Incontinence.
Official Title
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
Collaborators
Boehringer Ingelheim
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
458 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Primary Outcome Measure Information:
Title
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence
Secondary Outcome Measure Information:
Title
To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with predominant stress urinary incontinence.
7 or more incontinence episodes per week.
Exclusion Criteria:
Use of monoamine inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
London
State/Province
England
ZIP/Postal Code
SE3 7UQ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Duloxetine in the Treatment of Stress Urinary Incontinence.
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