RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF BENZOCAINE WIPES IN SUBJECTS WITH PREMATURE EJACULATION

Aim This study investigated the efficacy and safety of benzocaine wipes (PREBOOST) applied to the penis prior to intercourse for the treatment of men with premature ejaculation. Materials and methods The study utilized the local anesthetic benzocaine, in the form of wipes, for topical application to the glans penis prior to sexual intercourse. The design included three phases: screening and baseline, blinded randomized controlled, and an open-label phase with crossover of the placebo group to open-label active treatment. The two co-primary efficacy measures were the intravaginal ejaculatory latency time (IELT) measured by stopwatch, and the patient-reported outcome measured by the Index of Premature Ejaculation (IPE). Additional efficacy evaluation included a responder analysis using a predetermined 120s improvement in IELT as a responder threshold. Safety evaluation included patient-reported events along with a physical examination. Results The treatment phase showed a statistically significant increase from the baseline, in the treatment group (mean 165s) compared with the placebo group (mean 110s), P<0.007. After the second month of use, the treatment group had a mean IELT of 329.70s (+/- 21.37 SE) in comparison to the placebo group which had a mean IELT of 110.10s (+/- 9.90 SE) (P=0.001). The open-label phase showed further increase in IELT in the treatment group and a statistically significant increase in IELT in the placebo/ crossover group. Using the IPE, the men in the treatment group reported significantly higher sexual satisfaction (P=0.047) and greater improvement in distress (P=0.020) with a trend toward improvement in the ejaculatory control domain scores (P=0.093). The responder analysis showed a statistically significant response to the use of benzocaine versus placebo, attesting an IELT increase that was clinically meaningful. Benzocaine wipes were well tolerated by subjects and partners. Conclusion This randomized, placebo controlled clinical trial with crossover design showed that benzocaine wipes applied topically to the penis prior to sexual intercourse had a statistically significant prolongation of time to ejaculation, a clinically meaningful benefit, in the treatment of premature ejaculation. Furthermore, benzocaine wipes were well tolerated by the subjects and no evidence of transference to their female partners.