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OpenTrials
Completed

NCT Number: NCT00191204

Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

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Key information

Conditions

Urinary Incontinence Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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.

Peterborough, PE3 6JG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female out patients
  • Are ambulatory and are able to use a toilet independently and without difficulty.

Exclusion criteria

  • Use of monoamine oxidase inhibitors (MAOIs)

Treatment and study plan

Duloxetine

Drug

Primary outcomes

  1. The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.

Secondary outcomes

  1. The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Important dates

Study start
2001
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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