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

• Published in: International journal of clinical practice (Esher) Vol. 59; no. 2; pp. 143 - 149
• Main Authors: McMahon, C.G., Stuckey, B.G.A., Lording, D.W., Wittert, G.A., Murphy, A., Shin, J., Sutherland, P.D., Palmer, N.R., Lowy, M.P., Jesudason, D.R., Fredlund, P.
• Format: Journal Article
• Language: English
• Published: Oxford, UK; Malden, USA Blackwell Science Ltd 01.02.2005; Blackwell; Hindawi Limited
• Subjects: Adult; Aged; Australia; Biological and medical sciences; Carbolines - therapeutic use; Clinical trials; Double-Blind Method; Drug therapy; Erectile dysfunction; Erectile Dysfunction - drug therapy; General aspects; Humans; impotence; Male; Medical sciences; Middle Aged; oral pharmacotherapy; phosphodiesterase inhibitors; Phosphodiesterase Inhibitors - therapeutic use; Sexual disorders; Tadalafil; Treatment Outcome; Australia; Oceania; Vasodilator agent; 3',5'-Cyclic-GMP phosphodiesterase; Toxicity; Esterases; Phosphoric diester hydrolases; Randomization; Adult; Safety; impotence; Male genital diseases; Human; Blind; oral pharmacotherapy; Erection disorders; Enzyme; Treatment efficiency; Enzyme inhibitor; Erectile dysfunction; Medicine; Tadalafil; Carboline derivatives; Treatment; Placebo; Hydrolases; phosphodiesterase inhibitors
• ISSN: 1368-5031; 1742-1241
• DOI: 10.1111/j.1742-1241.2005.00451.x

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.