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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Duloxetine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No