NCT00190996

Brief Summary

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,765

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Urinary Incontinence, Stress

Outcome Measures

Primary Outcomes (1)

  • Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.

Secondary Outcomes (4)

  • Evaluate the maintenance of effect on IEF in long-term use

  • Kings Health Questionnaire

  • Patient Global Impression of Improvement Questionnaire

  • Safety effects

Interventions

Duloxetine HydrochlorideDRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female diagnosed with stress urinary incontinence

You may not qualify if:

  • Currently taking a monoamine oxidase inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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.

Surrey, KT24 6QT, United Kingdom

Location

Related Publications (1)

  • Cardozo L, Lange R, Voss S, Beardsworth A, Manning M, Viktrup L, Zhao YD. Short- and long-term efficacy and safety of duloxetine in women with predominant stress urinary incontinence. Curr Med Res Opin. 2010 Feb;26(2):253-61. doi: 10.1185/03007990903438295.

    PMID: 19929591DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

January 1, 2003

Study Completion

June 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

GB(1)