Prilocaine/lidocaine spray for the treatment of premature ejaculation: a dose- and time-finding study for clinical practice use

A eutectic mixture of prilocaine/lidocaine spray (Fortacin (TM), Recordati, Milan, Italy) has been approved for the management of patients affected by life-long premature ejaculation (PE), but to date, there is a lack of dose- or time-finding studies in the literature that indicate the best method of intake to optimize treatment outcomes. In this multicentre, randomized, two-phase study, we aimed to compare, in terms of treatment effectiveness (primary objective) and safety (secondary objective), different treatment regimens (various doses and times of drug delivery) of Fortacin (TM) in 91 patients affected with lifelong PE who were recruited at four different centres and randomized (1:1:1 ratio) into three different groups. The study included two phases: during the first phase (focused on time-finding), the same drug dose (three sprays) was taken at different intervals before intercourse (5, 15, 30 min). In the second phase (focused on dose finding), different drug doses (1, 3, 5 sprays) were taken at the same interval before intercourse (5 min). The main outcome measure instruments were self-measured intravaginal ejaculation latency time (sm-IELT), the premature ejaculation diagnostic tool (PEDT), and the International Index of Erectile Function-5 (IIEF-5). Furthermore, patients were asked to report any side effects that appeared during the study period. Our main study findings showed that the treatment regimen with three sprays of Fortacin (TM) administered 5 min before sexual intercourse showed the best results in terms of ejaculation time and control (Phase I, IELT 221 +/- 3.4, PEDT 7.7 +/- 0.3; Phase II, IELT 213 +/- 4.9, PEDT 7.8 +/- 0.4) with a safety profile that was identical to other treatment regimens. Based on these data, patients who are prescribed Fortacin (TM) should stick to this regimen to optimize treatment results.