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Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

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Lilly

Status and phase

Completed
Phase 3

Conditions

Urinary Incontinence, Stress

Treatments

Drug: placebo
Drug: duloxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00190814
F1J-MC-SBBO
6192

Details and patient eligibility

About

The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a strong need(urge) to urinate.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • female outpatients greater than or equal to 18 years of age.
  • experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study.
  • have an educational level and degree of understanding English.
  • are free of urinary tract infections.
  • have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.)

Exclusion criteria

  • have received treatment for incontinence within the last 5 years.
  • suffer from severe constipation.
  • currently nursing or breast feeding.
  • any nervous system disease that would affect normal urinary function.
  • any extension of internal organs beyond the vaginal opening.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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