Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190827
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007

September 12, 2005
January 24, 2007
September 2003
Not Provided
  • Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase.
  • Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.
Same as current
Complete list of historical versions of study NCT00190827 on ClinicalTrials.gov Archive Site
  • Assessment of overall patient safety.
  • Reduction of IEFs using standardized instruments.
Same as current
Not Provided
Not Provided
 
Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)
The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence

The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Urinary Incontinence, Stress
  • Drug: duloxetine
  • Drug: placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
May 2006
Not Provided

Inclusion Criteria:

  • female outpatients > or = 18 years of age
  • experience episodes of stress urinary incontinence
  • must have an educational level and degree of understanding English
  • are free of urinary tract infections
  • can use the toilet independently

Exclusion Criteria:

  • any in or outpatient surgery in the last six months
  • suffer from severe constipation
  • extension of any internal organs beyond vaginal opening
  • currently breastfeeding
  • any nervous diseases affecting normal urinary function
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Puerto Rico,   Spain
 
NCT00190827
6195, F1J-MC-SBBR
Not Provided
Not Provided
Eli Lilly and Company
Boehringer Ingelheim
Study Director: Call 1-877-CTLILLY(1-877-285-4559 or 1-317-615-4559) Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP