Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction

This is a multicentre, cluster-randomized, open-label flexible dose study with a 2x2 factorial design with administration of vardenafil at a dose of 5, 10 and 20 mg doses in males with erectile dysfunction.The treatment period is for 12 weeks, after a 4 week unmedicated period for subjects taking ED medication. For ED treatment-naïve subjects (ie, previously not treated with ED medication), the unmedicated period can be only 2 weeks.Approximately 150 investigational centres may be utilised with approximately 10 subjects screened and entered into a 4 week treatment free period at Visit 1 to subsequently enroll approximately 1380 subjects to therapy. Each centre should enroll 10 subjects. Sites should try to recruit approximately 50% of subjects who have not previously tried oral PDE5 inhibitor therapy for erectile dysfunction. An attempt should be made to enroll subjects whose partners are interested in being involved.Sites will be randomized in a 1:1:1:1 ratio to receive either the education intervention at the Primary care Physician (PCP) level, at the subject level, both levels or no intervention (usual care). The PCP education program is an accredited CME program and included a comprehensive overview on the screening and diagnosis of ED, the available treatment options and appropriate treatment selection, as well as subject and partner counseling. The subject education was a two-pronged approach which included physician-to-subject instruction and a direct-to-subject education method. After the unmedicated period, treatment was initiated with vardenafil 10 mg tablets for 4 weeks. This will be followed by a flexible dose titration period of 4 weeks during which subjects may maintain the previous dosage regimen or will step up to 20 mg of vardenafil or will step down to 5 mg vardenafil. There is a final 4 week treatment period where the previous dosage regimen is either maintained, increased or decreased by one step according to the three applicable dosage strengths