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 NIHConsensus Statement (the inability to achieve or maintain penile erection sufficientfor satisfactory sexual performance)

• Stable, heterosexual relationship for more than six months

• Documented written Informed Consent, from both the patient and his partner, afterreceiving adequate previous information and prior to any study specificprocedures.

• An ED-EQoL score < or = 15.- An IIEF score < or = 25.

Exclusion Criteria:

• Presence of penile anatomical abnormalities (eg. penile fibrosis or Peyronie'sdisease) 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 (exceptstable angina), or life-threatening arrhythmia within the prior 6 months.

• Atrial tachyarrhythmia (eg. atrial fibrillation/flutter) with a heart rate of >100beats 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: potentHIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazoleand ketoconazole (topical forms are allowed) or erythromycin.