Vardenafil Compared With Tadalafil When Sexual Intercourse is Attempted up to 45 Minutes After Dosing

Journal of Sex Research, Feb, 2006

Vardenafil Compared With Tadalafil When Sexual Intercourse is Attempted up to 45 Minutes After Dosing, Douglas Lording, Melbourne Andrology Center, Australia; Thierry Lebret, Hospital Foch, France; Chris McMahon, Australian Center for Sexual Health; Ignacio Moncada, Hospital General Universitario Gregorio Maranon, Spain; Nam-Cheol Park, Pusan National University, Korea; Ken Purvis, Andrology Center, Norway; Jeremy Roberts, GlaxoSmithKline, United Kingdom; Francesco Montorsi, Universita Vita Salute san Raffaele, Italy

We compared the efficacy of vardenafil 10 mg (VAR) with tadalafil 10 mg (TAD) when intercourse was attempted less than or equal to 45 minutes post-dosing. In this 4-week study, 759 men with erectile dysfunction (ED) for more than 6 months received VAR or TAD, with instructions to attempt penetration less than or equal to 45 minutes post-dosing. Primary endpoint was mean per-patient success rate for successful completion of intercourse (Sexual Encounter Profile question 3 [SEP3]) within 45 minutes for all doses taken with the intent of intercourse. A further subset analysis was undertaken including only those where intercourse was attempted within 45 minutes. SEP2 (penetration success rates) and International Index of Erectile Function, erectile function (IIEF-EF) domain scores were also assessed. At baseline, mean EF domain scores suggested moderate ED in both treatment groups: VAR 14.1 (n = 368) and TAD 13.8 (n = 363). Overall least-square mean SEP3 per-patient success rates were significantly higher with VAR vs. TAD, both for all valid doses taken within 45 minutes with the intent of intercourse and doses only where intercourse was attempted within 45 minutes. SEP2 success rates were also significantly greater with VAR vs. TAD, both for doses within 45 minutes taken with the intent of intercourse and for doses only where intercourse was attempted within 45 minutes. EF domain scores improved to 22.8 with VAR (mild ED) and 21.3 (mild to moderate ED) with TAD at week 4. VAR and TAD were generally well-tolerated. The most frequently-reported adverse events included headache, flushing, and nasal congestion. Overall, intercourse completion rates with VAR were superior to those with TAD during the time interval after deciding to have sex in which most couples engage in sexual activity.