To Evaluate the Safety of Duloxetine in Patients With Stress Urinary Incontinence

Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190645

Enrollment

600

Registered

2005-09-19

Start date

2001-02-28

Completion date

2006-05-31

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Brief summary

The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from Stress Urinary Incontinence.

Interventions

DRUGDuloxetine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Successfully completed the protocol for Study F1J-MC-SBAV. \-

Exclusion criteria

Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry. Use of excluded medications within 14 days prior to study entry or at any time during the study. \-

Design outcomes

Primary

Measure	Time frame
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence(SUI).	—

Secondary

Measure	Time frame
To collect data to demonstrate the maintenance of effect of duloxetine as measured by Patient Global Impression of Improvement (PGI-I) questionnaire.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026