To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence
This study has been completed.
Information provided by:
Eli Lilly and Company
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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.
Stress Urinary Incontinence
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Primary Outcome Measures:
- To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI).
Secondary Outcome Measures:
- To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) questionnaire.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Successfully completed the protocol for Study F1J-MC-SBAV.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190645
|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 |
|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 |
Eli Lilly and Company
||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
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 12, 2005
||January 24, 2007
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 19, 2014
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Signs and Symptoms
Adrenergic Uptake Inhibitors
Central Nervous System Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents
Serotonin Uptake Inhibitors