Efficacy and Safety of Duloxetine

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