To Evaluate the Safety in Patients Taking Duloxetine for Stress Urinary Incontinence

Lilly

Status and phase: Completed; Phase 3

Conditions: Stress Urinary Incontinence

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190632

2690

F1J-MC-SBAY

Details and patient eligibility

About

This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Have had symptoms of SUI for at least 3 months prior to study entry.

Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).

Ambulatory and able to use a toilet independently and without difficulty.

Exclusion criteria

Subjects who participated or were discontinued from any previous studies investigating duloxetine.

Use of excluded medications within 14 days prior to study entry or at any time during the study.

Subjects who currently have or have had a history of urogenital cancer.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)