Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

Completed · Phase 3 · Has a placebo group

Conditions studied: Urinary Incontinence, Stress

In brief

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 strong need(urge) to urinate.

Key facts

Study ID

NCT00190814

Run by

Eli Lilly and Company

People needed

600

Starts

2003-09-01

Expected to finish

2006-05-01

Last updated by the study team

2007-01-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• 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
• 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
• 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

Full record on ClinicalTrials.gov

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