Efficacy and Safety of Duloxetine, Placebo and Pelvic Floor Muscle Training in Subjects With Stress Urinary Incontinence

Completed · Phase 2 · Has a placebo group

Conditions studied: Urinary Stress Incontinence

In brief

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

Key facts

Study ID

NCT00190606

Run by

Eli Lilly and Company

People needed

200

Starts

2002-01-01

Expected to finish

2006-04-01

Last updated by the study team

2007-01-26

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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