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Sponsors and Collaborators: |
Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00190905 |
The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.
Condition | Intervention | Phase |
---|---|---|
Stress Urinary Incontinence |
Drug: duloxetine HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-Morbidities With Stress Urinary Incontinence: Evaluation of Efficacy and Safety |
Estimated Enrollment: | 4000 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Indiana | |
For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
indianapolis, Indiana, United States |
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 |
Study ID Numbers: | 8363, F1J-US-SBCD |
Study First Received: | September 12, 2005 |
Last Updated: | July 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00190905 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Urination Disorders Psychotropic Drugs Stress Serotonin Uptake Inhibitors Duloxetine |
Serotonin Signs and Symptoms Urinary Incontinence, Stress Dopamine Urologic Diseases Urinary Incontinence Dopamine Agents Antidepressive Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Urination Disorders Physiological Effects of Drugs Psychotropic Drugs Stress Serotonin Uptake Inhibitors Pharmacologic Actions |
Duloxetine Urological Manifestations Signs and Symptoms Serotonin Agents Urinary Incontinence, Stress Pathologic Processes Urologic Diseases Therapeutic Uses Dopamine Agents Urinary Incontinence Central Nervous System Agents Antidepressive Agents |