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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: | NCT00190606 |
The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence
Condition | Intervention | Phase |
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Urinary Stress Incontinence |
Drug: Duloxetine Procedure: Pelvic Floor Muscle Training (PFMT) Procedure: Imitation PFMT Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Duloxetine Compared With Placebo,Pelvic Floor Muscle Training, and Combined Duloxetine/Pelvic Floor Muscle Training in Subjects With Moderate to Sever Stress Urinary Incontinence |
Estimated Enrollment: | 200 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Weston, Florida, United States, 33331 | |
Netherlands | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
Nieuwegein, Netherlands, 3435 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Study ID Numbers: | 2615, F1J-MC-SBAF |
Study First Received: | September 12, 2005 |
Last Updated: | January 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00190606 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 |