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OpenTrials
Completed

NCT Number: NCT00190996

Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.

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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 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.

Surrey, KT24 6QT, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female diagnosed with stress urinary incontinence

Exclusion criteria

  • Currently taking a monoamine oxidase inhibitor

Treatment and study plan

duloxetine hydrochloride

Drug

Placebo

Drug

Primary outcomes

  1. Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.

Secondary outcomes

  1. Evaluate the maintenance of effect on IEF in long-term use

  2. Kings Health Questionnaire

  3. Patient Global Impression of Improvement Questionnaire

  4. Safety effects

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

Important dates

Study start
2003
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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