An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to assess the effect of Alfuzosin in treating Erectile Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline in erectile function (EF) domain of International Index of Erectile Function (IIEF).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chesapeake Urology Research Associates
• Collaborator: Sanofi
• Treatments: Alfuzosin

Criteria

Inclusion Criteria:

• Male, 30-69 years of age

• Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF

• AUA score of less than or equal to 14

• Negative urinalysis with no evidence of a Urinary Tract Infection

Exclusion Criteria:

• Blood pressure < 90/50 or > 170/110

• Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)

• Diabetes Mellitus

• History of PSA > 10

• History of confirmed or suspected prostate cancer

• History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN

• On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization

• Receive treatment with other investigational agents within 30 days prior to enrollment