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Trial record 76 of 197 for:    (hispanic OR latina) AND (woman OR women OR female)

Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190905
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 25, 2006
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Drug: duloxetine HCl Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 4000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Measures :
  1. Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00190905

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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
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
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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

Layout table for additonal information Identifier: NCT00190905     History of Changes
Other Study ID Numbers: 8363
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 25, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents