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

Autor: Ridwan Shabsigh, Michael A. Perelman, Robert H. Getzenberg, Allison Grant, Jed Kaminetsky
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Journal of Men's Health, Vol 15, Iss 3 (2019)
Druh dokumentu: article
ISSN: 1875-6859
DOI: 10.22374/jomh.v15i3.156
Popis: 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
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