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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00190814

Collaborator

Boehringer Ingelheim (Industry)

600

Enrollment

Locations

Duration (Months)

200

Patients Per Site

6.3

Patients Per Site Per Month

Study Details

Study Description

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 strong need(urge) to urinate.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Stress	Drug: duloxetine Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Duloxetine Compared With Placebo in Women With Symptoms of Mixed Urinary Incontinence.

Study Start Date :

Sep 1, 2003

Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint. []

Secondary Outcome Measures

Additional assessments of incontinence episode frequency using various standardized instruments will be performed. []
To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatment-emergent adverse events. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

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) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company