Status:
COMPLETED
Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Urinary Stress Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence
Eligibility Criteria
Inclusion
- Female
- Between 18 and 75 years of age
- Confirmed pure genuine stress incontinence
- Have discrete episodes of incontinence
- Have pelvic organ prolapse of no greater than Stage II
Exclusion
- Positive urine culture at visit 1
- Had formal PFMT with instruction
- Use of MAOI or other excluded medications
- Use of any anti-incontinence device, vaginal pessaries or any medication prescribed for the treatment of urinary incontinence
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00190606
Start Date
January 1 2002
End Date
April 1 2006
Last Update
January 26 2007
Active Locations (2)
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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 - 5 hours, EST), or speak with your personal physician
Weston, Florida, United States, 33331
2
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 - 5 hours, EST), or speak with your personal physician
Nieuwegein, Netherlands, 3435