title: 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.
abstract: 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.
authors.affiliation: Australian Centre for Sexual Health, St Leonards, Sydney, New South Wales 2011, Australia. cmcmahon@acsh.com.au
authors.forename: C G
authors.initials: CG
authors.lastname: McMahon
authors.forename: B G A
authors.initials: BG
authors.lastname: Stuckey
authors.forename: D W
authors.initials: DW
authors.lastname: Lording
authors.forename: G A
authors.initials: GA
authors.lastname: Wittert
authors.forename: A
authors.initials: A
authors.lastname: Murphy
authors.forename: J
authors.initials: J
authors.lastname: Shin
authors.forename: P D
authors.initials: PD
authors.lastname: Sutherland
authors.forename: N R
authors.initials: NR
authors.lastname: Palmer
authors.forename: M P
authors.initials: MP
authors.lastname: Lowy
authors.forename: D R
authors.initials: DR
authors.lastname: Jesudason
authors.forename: P
authors.initials: P
authors.lastname: Fredlund
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia; D002243:Carbolines / Q000627:therapeutic use*; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D000068581:Tadalafil; D016896:Treatment Outcome
chemical_list: D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil