Open Label Phase III Duloxetine Study for 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

NCT00191204

Enrollment

363

Registered

2005-09-19

Start date

2001-09-30

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

Urinary Incontinence Stress

Brief summary

The purpose of this study is to monitor the long term safety of duloxetine in the treatment of 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

* Female out patients * Are ambulatory and are able to use a toilet independently and without difficulty.

Exclusion criteria

* Use of monoamine oxidase inhibitors (MAOIs)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

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