Cardiovascular and metabolic conditions are risk factors for ED and are common among men with ED. The purpose of this study was to assess the safety and effectiveness of, and notably patient satisfaction with, vardenafil treatment in a general population of men with ED, including those with underlying conditions, over a period of 3-12 months. A prospective, multicenter, noninterventional study was carried out in Germany between July 2005 and January 2007. Men aged > or =18 years (n=7088) who were prescribed vardenafil for ED, irrespective of previous ED treatment or underlying conditions, were eligible for inclusion. Safety, effectiveness and patient satisfaction data were collected by physician case report forms (CRFs) after 3 months, with optional self-completed patient questionnaires at baseline, 3, 6, 9 and 12 months. The intent-to-treat population included 6474 patients, and 1331 patients returned at least one questionnaire. No serious adverse events were related to vardenafil use. CRF data showed that 93.0% of patients reported improved erections after 3 months, with similar rates of improvement among men with underlying conditions. High levels of patient satisfaction with vardenafil regarding effectiveness of treatment, time to onset and duration of action were sustained throughout the study.