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OpenTrials
Completed

NCT Number: NCT00190645

To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.

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Key information

Conditions

Stress Urinary Incontinence 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, Oakville, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Successfully completed the protocol for Study F1J-MC-SBAV.

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Exclusion criteria

Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

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Treatment and study plan

Duloxetine

Drug

Primary outcomes

  1. To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI).

Secondary outcomes

  1. To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) 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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