Duloxetine in the Treatment of Stress Urinary Incontinence.

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191087
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
April 2001
Not Provided
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence
Same as current
Complete list of historical versions of study NCT00191087 on ClinicalTrials.gov Archive Site
To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire.
Same as current
Not Provided
Not Provided
 
Duloxetine in the Treatment of Stress Urinary Incontinence.
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence.

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence, Stress
Drug: Duloxetine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
458
May 2006
Not Provided

Inclusion Criteria:

  • Women with predominant stress urinary incontinence.
  • 7 or more incontinence episodes per week.

Exclusion Criteria:

  • Use of monoamine inhibitors.
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00191087
2686, F1J-MC-SBAU
Not Provided
Not Provided
Eli Lilly and Company
Boehringer Ingelheim
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
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP