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| Sponsors and Collaborators: |
Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00190996 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence, Stress |
Drug: Duloxetine Hydrochloride Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 2765 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | June 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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. | |
| Surrey, United Kingdom, KT24 6QT | |
| 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: | 8049, F1J-EW-SBCC |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00190996 |
| 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 |
