Status:
COMPLETED
Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical condition...
Eligibility Criteria
Inclusion
- Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.
- Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.
- Must provide informed consent.
- Must not have urinary tract infection at screening.
Exclusion
- Sensitivity to duloxetine
- Unstable medical conditions
- Pregnancy
- Acute liver damage
- Suicidal in the opinion of the investigator
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT00190905
Start Date
February 1 2004
End Date
July 1 2005
Last Update
July 25 2006
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Indianapolis, Indiana, United States