Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00190996
Collaborator
Boehringer Ingelheim (Industry)
2,765
1
41
67.5
Study Details
Study Description
Brief Summary
The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence
Study Start Date
:
Jan 1, 2003
Study Completion Date
:
Jun 1, 2006
Outcome Measures
Primary Outcome Measures
- Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency. []
Secondary Outcome Measures
- Evaluate the maintenance of effect on IEF in long-term use []
- Kings Health Questionnaire []
- Patient Global Impression of Improvement Questionnaire []
- Safety effects []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Female diagnosed with stress urinary incontinence
Exclusion Criteria:
- Currently taking a monoamine oxidase inhibitor
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. | Surrey | United Kingdom | KT24 6QT |
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.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00190996
Other Study ID Numbers:
- 8049
- F1J-EW-SBCC
First Posted:
Sep 19, 2005
Last Update Posted:
Jan 26, 2007
Last Verified:
Jan 1, 2007
Additional relevant MeSH terms: