Objective. To describe the pattern of sexual attempts by men with erectile dysfunction (ED) taking tadalafil 20 mg on demand or on an alternative dosing regimen, 3 times/week, and to assess changes in sexual behavior when the patients were exposed to the alternative regimen.
Design and Methods. Scheduled use versus on-demand regimen evaluation (SURE) is a multicenter, crossover, open-label study conducted in 14 European countries. Men with ED (N = 4,262) were randomized to tadalafil 20 mg on-demand treatment (maximum one dose per day and before sexual activity) or 3 times/week for 5–6 weeks. After a 1-week washout period, patients were crossed over to the alternative regimen for 5–6 weeks.
Results. Nearly half (47%) of the attempts on the on-demand regimen and 71% of the attempts on the 3 times/week treatment were performed by patients more than 4 hours post dosing. Sexual activity occurred throughout the week on both regimens, with the highest percentage of attempts made during the weekend (50% on on-demand and 48% on 3 times/week) and evening and morning hours. The efficacy of tadalafil was more than 70% mean-per-patient success rate (Sexual Encounter Profile question 3) regardless of the time interval post dosing.
Conclusions. Patients on tadalafil changed their sexual behavior significantly when on an alternative dosing regimen (3 times/week) and had sexual attempts distributed over a wide period of time post dosing. A substantial number of sexual attempts were performed beyond the first 4 hours post dosing on both regimens (47% for on-demand and 71% for 3 times/week) and preferably in the evening and morning hours. Tadalafil was efficacious regardless of the time interval post dosing—i.e., up to 36 hours. The two treatment regimens, on-demand and 3 times/week, provide an additional option and unique flexibility in dosing for men with ED and their partners. Moncada I, Damber J-E, Mirone V, Wespes E, Casariego J, Chan M, and Varanese L. Sexual intercourse attempt patterns with two dosing regimens of tadalafil in men with erectile dysfunction: Results from the SURE study in 14 European countries. J Sex Med 2005;2:668–674.