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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190905
First Posted: September 19, 2005
Last Update Posted: July 25, 2006
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.
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
  Purpose
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 Intervention Phase
Stress Urinary Incontinence Drug: duloxetine HCl Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

Estimated Enrollment: 4000
Study Start Date: February 2004
Estimated Study Completion Date: July 2005
  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00190905


Locations
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
Investigators
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
  More Information

ClinicalTrials.gov Identifier: NCT00190905     History of Changes
Other Study ID Numbers: 8363
F1J-US-SBCD
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: July 25, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents