Status:

COMPLETED

To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

Boehringer Ingelheim

Conditions:

Stress Urinary Incontinence

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.

Eligibility Criteria

Inclusion

  • Have had symptoms of SUI for at least 3 months prior to study entry.
  • Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).
  • Ambulatory and able to use a toilet independently and without difficulty.
  • \-

Exclusion

  • Subjects who participated or were discontinued from any previous studies investigating duloxetine.
  • Use of excluded medications within 14 days prior to study entry or at any time during the study.
  • Subjects who currently have or have had a history of urogenital cancer.

Key Trial Info

Start Date :

March 1 2001

Trial Type :

INTERVENTIONAL

End Date :

April 1 2006

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT00190632

Start Date

March 1 2001

End Date

April 1 2006

Last Update

January 26 2007

Active Locations (1)

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Cleveland, Ohio, United States, 44122