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Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190996
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Drug: Duloxetine Hydrochloride Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2765 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : January 2003
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female diagnosed with stress urinary incontinence

Exclusion Criteria:

  • Currently taking a monoamine oxidase inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190996

United Kingdom
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, United Kingdom, KT24 6QT
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00190996     History of Changes
Other Study ID Numbers: 8049
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents