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  • Title: Sexual intercourse attempt patterns with two dosing regimens of tadalafil in men with erectile dysfunction: results from the SURE study in 14 European countries.
    Author: Moncada I, Damber JE, Mirone V, Wespes E, Casariego J, Chan M, Varanese L.
    Journal: J Sex Med; 2005 Sep; 2(5):668-74. PubMed ID: 16422825.
    Abstract:
    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.
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