To determine the time course for the first successful intercourse attempt in 343 men with erectile dysfunction (ED) administered 5mg tadalafil versus placebo once daily.

Analyses included pooled data from 2 multi-center, randomized, double-blind, placebo-controlled studies of tadalafil dosed once daily in men with ED. The percentage of patients with a successful intercourse attempt over the first 10 days of therapy was assessed by patient response to Sexual Encounter Profile (SEP) question 3 (’Did your erection last long enough for you to have successful intercourse?’). Of the 343 men with SEP data collected, 331 (placebo n=138; 5mg tadalafil n=193) had an attempt within the first 10 days of the study. Patients were 57.9 ± 11.2 years old (mean± SD) and had ED of any etiology or severity.

Beginning at day 2, and continuing through day 10, the percentage of patients who reported having had at least one successful intercourse attempt was significantly greater in patients receiving 5mg tadalafil as compared with placebo (all p<0.001). At day 10, 131/193 (67.9%) 5mg tadalafil-treated patients, as compared with 52/138 (37.7%) placebo-treated patients reported having had at least one successful intercourse attempt (p<0.0001).

Beginning after 2 days of treatment, tadalafil 5mg dosed once daily significantly improved menʼs ability to successfully engage in sexual intercourse, as compared with placebo. This finding is robust compared to other days on treatment.