Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

This study has been completed.

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191204

Purpose

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

Condition	Intervention	Phase
Urinary Incontinence Stress	Drug: Duloxetine	Phase III

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	363
Study Start Date:	September 2001
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191204

Locations

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.
Peterborough, United Kingdom, PE3 6JG

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 Mon - Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Study ID Numbers:	5309, F1J-MC-SBBM
Study First Received:	September 12, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00191204
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders

Stress
Urinary Incontinence
Serotonin
Duloxetine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Urological Manifestations
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009