To Evaluate the Safety in Patients Taking Duloxetine 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

NCT00190632

Enrollment

600

Registered

2005-09-19

Start date

2001-03-31

Completion date

2006-04-30

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

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.

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

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.

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 the Patient Global Impression of Improvement (PGI-I) questionnaire.	—

Countries

United States

Outcome results

None listed

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