Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stress Urinary Incontinence
Intervention: duloxetine HCl (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company
Summary
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.
Clinical Details
Official title: Study of Duloxetine HCl in Women of Different Demographic Characteristics and Co-Morbidities With Stress Urinary Incontinence: Evaluation of Efficacy and Safety
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Percent change in weekly incontinence episode frequency as noted by patient diaries from baseline to endpoint in Hispanic women and also in African American women with SUI or stress predominant mixed urinary incontinence
Secondary outcome: Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
Sensitivity to duloxetine
Unstable medical conditions
Pregnancy
Acute liver damage
Suicidal in the opinion of the investigator
Locations and Contacts
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
Additional Information
Starting date: February 2004
Ending date: July 2005
Last updated: July 21, 2006
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