A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

Inclusion Criteria: * Males with erectile dysfunction for more than six months according to the NIH Consensus Statement (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance) * Stable, heterosexual relationship for more than six months * Documented written Informed Consent, from both the patient and his partner, after receiving adequate previous information and prior to any study specific procedures. * An ED-EQoL score \< or = 15.- An IIEF score \< or = 25. Exclusion Criteria: * Presence of penile anatomical abnormalities (eg. penile fibrosis or Peyronie's disease) that would significantly impair erectile function. * History of radical prostatectomy. - Retinitis pigmentosa. * History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.- Unstable angina pectoris. * History of myocardial infarction, stroke, electrocardiographic ischaemia (except stable angina), or life-threatening arrhythmia within the prior 6 months. * Atrial tachyarrhythmia (eg. atrial fibrillation/flutter) with a heart rate of \>100 beats per minute at screening. * Child-Pugh class B liver disease or liver function abnormalities. * Clinically significant chronic haematological disease or bleeding disorder * History of significant peptic ulcer disease within one year before Visit 1 * Resting hypotension (a resting systolic blood pressure of \<90 mm Hg) or hypertension (a resting systolic blood pressure \>170 mm Hg or a resting diastolic blood pressure \>110 mm Hg). * Symptomatic postural hypotension within the six months of Visit 1. * Uncontrolled diabetes mellitus (haemoglobin A1c \> 12%). * Patients who are taking nitrates or nitric oxide donors (e.g. molsidomine). * Patients who are taking anticoagulants, with the exception of anti-platelet agents. * Patients who are taking androgens (e.g. testosterone), trazodone or anti-androgens. * Patients who are taking the following inhibitors of cytochrome P 450 CYP 3A4: potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin.