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

Authors

  • C.G. McMahon,

    Corresponding author
    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 1 B.G.A. Stuckey,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 2 D.W. Lording,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 3 G.A. Wittert,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 4 A. Murphy,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 5 J. Shin,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 6 P.D. Sutherland,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 4 N.R. Palmer,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 7 M.P. Lowy,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • 8 D.R. Jesudason,

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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  • and 4 P. Fredlund 5

    1. Australian Centre for Sexual Health,1St Leonards, Sydney, New South Wales, The Keogh Institute for Medical Research,2Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, St Frances Xavier Cabrini Hospital,3Coonil Crescent, Malvern, Victoria, University of Adelaide,4Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia, ICOS Corporation,5Bothell, Washington, USA, Eli Lilly Canada,6Toronto, Ontario, Canada, The Keogh Institute for Medical Research,7Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australian Centre for Sexual Health,8St Luke's Hospital Complex, Sydney, New South Wales, Australia
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*Dr Christopher G. McMahon, Australian Centre for Sexual Health, Suites 2–4 1a Berry Road, St Leonards, Sydney, New South Wales 2011, Australia
Tel.: +61 02 9437 3906
Fax: +61 02 9906 5900
Email: cmcmahon@acsh.com.au

Summary

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 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.

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