Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

Inclusion Criteria:

• Stable heterosexual relationship
• History of erectile dysfunction for at least 6 months
• IIEF- EF Domain entry score (at Visit 2): >21 points
• Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
• Subjects motivated for erectile dysfunction treatment
• Documented, dated, written informed consent

Exclusion Criteria:

• Any underlying cardiovascular condition
• History of myocardial infarction
• Uncontrolled atrial fibrillation
• Resting hypotension
• Postural hypotension within 6 months of Visit 1
• History of congenital QT prolongation
• Bleeding disorder
• History of prostatectomy because of prostate cancer
• Hereditary degenerative retinal disorders
• History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
• 29 Additional Exclusion Criteria