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

Christopher 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. Fredlund

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The 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 improve 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.

Original languageEnglish
Pages (from-to)143-149
Number of pages7
JournalInternational Journal of Clinical Practice
Issue number2
Publication statusPublished or Issued - Feb 2005


  • Erectile dysfunction
  • Impotence
  • Oral pharmacotherapy
  • Phosphodiesterase inhibitors

ASJC Scopus subject areas

  • Medicine(all)

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