Status:
COMPLETED
Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Urinary Stress Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence
Eligibility Criteria
Inclusion
- Female
- Between 18 and 75 years of age
- Diagnosis of GSI
- Have discrete episodes of incontinence
Exclusion
- Positive urine culture at visit 1
- Use of MAOI
- Have had continence or urethral surgery
- Use of anti-incontinence device, vaginal pessaries or medications for the treatment of urinary incontinence
- Began pelvic floor muscle exercises within 6 months prior to study entry.
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00190567
Start Date
October 1 2001
End Date
April 1 2006
Last Update
January 26 2007
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician
Indianapolis, Indiana, United States, 46202