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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Boehringer Ingelheim
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Sensitivity to duloxetine

• Unstable medical conditions

• Pregnancy

• Acute liver damage

• Suicidal in the opinion of the investigator