Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

Phase 3CompletedNCT00191204

Eli Lilly and Company363 enrolled

Overview

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

363

Conditions

Urinary Incontinence Stress

Interventions

DuloxetineDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female out patients * Are ambulatory and are able to use a toilet independently and without difficulty. Exclusion Criteria: * Use of monoamine oxidase inhibitors (MAOIs)

Locations (1)

For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours EST), or speak with your personal physician.

Peterborough, United Kingdom

Outcomes

Primary Outcomes

The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.

Secondary Outcomes

The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.

Data from ClinicalTrials.gov

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