A 6-month study of the efficacy and safety of tadalafil in the treatment of erectile dysfunction: A randomised double-blind parallel-group placebo-controlled study in Australian men

The definitive version is available at www.blackwell-synergy.comThe efficacy and safety of tadalafil for the treatment of erectile dysfunction (ED) were assessed in a 6-month, randomised, double-blind, placebo-controlled study. Australian men with mild, moderate or severe ED of organic, psychogenic or mixed aetiology were randomised to tadalafil 20 mg as needed (n = 93) or placebo (n = 47). Efficacy assessments included the international index of erectile function (IIEF) and the sexual encounter profile (SEP) diary. Tadalafil significantly improved erectile function compared with placebo (p < 0.001, all measures). At the end of the study, the mean per-patient proportion of successful sexual intercourse attempts (SEP question three) was 73.5% for patients treated with tadalafil and 26.8% for placebo-treated patients. Improved erections were reported by 78% of tadalafil-treated patients compared to 12.8% of placebo-treated patients. The most common treatment-emergent adverse events--headache and dyspepsia--were generally mild or moderate. Tadalafil was effective and well tolerated in Australian men with mild to severe ED.C.G. McMahon, B.G.A. Stuckey, D.W. Lording, G.A. Wittert, A. Murphy, J. Shin, P.D. Sutherland, N.R. Palmer, M.P. Lowy, D.R. Jesudason, P. Fredlun