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| Sponsors and Collaborators: |
Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00190645 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Urinary Incontinence |
Drug: Duloxetine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence |
| Estimated Enrollment: | 600 |
| Study Start Date: | February 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 |
Inclusion Criteria:
Successfully completed the protocol for Study F1J-MC-SBAV.
-
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.
-
Contacts and Locations| United States, Colorado | |
| 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 | |
| Denver, Colorado, United States, 80220 | |
| Canada, Ontario | |
| 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, L6H3P1 | |
| 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 |
More Information
| Study ID Numbers: | 2688, F1J-MC-SBAW |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00190645 |
| Health Authority: | United States: Food and Drug Administration |
|
Signs and Symptoms Dopamine Urinary Incontinence, Stress Urologic Diseases Urination Disorders |
Stress Urinary Incontinence Serotonin Duloxetine |
|
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 |
