Status:
COMPLETED
Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a s...
Eligibility Criteria
Inclusion
- female outpatients greater than or equal to 18 years of age.
- experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study.
- have an educational level and degree of understanding English.
- are free of urinary tract infections.
- have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.)
Exclusion
- have received treatment for incontinence within the last 5 years.
- suffer from severe constipation.
- currently nursing or breast feeding.
- any nervous system disease that would affect normal urinary function.
- any extension of internal organs beyond the vaginal opening.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00190814
Start Date
September 1 2003
End Date
May 1 2006
Last Update
January 26 2007
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
Baltimore, Maryland, United States, 21204
2
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
London, Ontario, Canada, N6A 4L2
3
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY(1-877-285-4559, 1-317-615-4559), Monday-Friday, 9 am to 5 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician
London, United Kingdom, W2 1NY