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Efficacy and Safety of Duloxetine

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Lilly

Status and phase

Completed
Phase 3

Conditions

Urinary Stress Incontinence

Treatments

Drug: Duloxetine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00190619
2624
F1J-MC-SBAM

Details and patient eligibility

About

The purpose of this study is to monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female out patients.
  • Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion criteria

  • Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.
  • Suffer from severe constipation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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