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OpenTrials
Completed

NCT Number: NCT00190632

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

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.

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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

Cleveland, Ohio, 44122, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

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Exclusion criteria

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.

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 the 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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