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

Lilly

Status and phase: Completed; Phase 4

Conditions: Stress Urinary Incontinence

Treatments: Drug: duloxetine HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00190905

8363

F1J-US-SBCD

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)