Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.
Completed · Phase 4
Conditions studied: Stress Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT00190905
- Run by
- Eli Lilly and Company
- People needed
- 4000
- Starts
- 2004-02-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2006-07-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.
- Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.
- Must provide informed consent.
- Must not have urinary tract infection at screening.
You may not qualify if…
- Sensitivity to duloxetine
- Unstable medical conditions
- Pregnancy
- Acute liver damage
- Suicidal in the opinion of the investigator
Where it is running
- 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
Full record on ClinicalTrials.gov
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