Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

NCT00190905 | Completed Phase 4

• 2 other identifiers: 8363F1J-US-SBCD
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Percent change in weekly incontinence episode frequency as noted by patient diaries from baseline to endpoint in Hispanic women and also in African American women with SUI or stress predominant mixed urinary incontinence

Secondary Outcomes (1)

• Baseline to endpoint analysis for the Patient Global Impression of Improvement, Incontinence Quality of Life, and pad use as noted by patient diaries

Interventions

duloxetine HCl DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.
• Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.
• Must provide informed consent.
• Must not have urinary tract infection at screening.

You may not qualify if:

• Sensitivity to duloxetine
• Unstable medical conditions
• Pregnancy
• Acute liver damage
• Suicidal in the opinion of the investigator

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic 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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2004
• Study Completion: July 1, 2005
• Last Updated: July 25, 2006

Record last verified: 2006-07

Locations

US (1)