1493 PSD 502: A SECOND PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN PREMATURE EJACULATION (PE) PATIENTS IN THE US AND EUROPE

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy II1 Apr 20101493 PSD 502: A SECOND PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN PREMATURE EJACULATION (PE) PATIENTS IN THE US AND EUROPE Culley Carson, Ira Sharlip, and Mike Wyllie Culley CarsonCulley Carson Chapel Hill, NC More articles by this author , Ira SharlipIra Sharlip San Francisco, CA More articles by this author , and Mike WyllieMike Wyllie London, United Kingdom More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1230AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES There is no therapy approved in the US for PE. PSD502 is a novel, locally-applied, aerosol formulation of lidocaine and prilocaine which selectively desensitizes the glans of the penis. The objectives of this study were to assess further the clinical benefit and safety of PSD502 in men with PE when used on an “as needed” basis. METHODS Men with primary PE and an IELT of < 1 minute were randomized in a 2:1 ratio from 38 centers in the US, Canada and Poland, to apply PSD502 or placebo to the glans penis 5 min before intercourse. Efficacy was assessed by changes in intravaginal ejaculatory latency time (IELT) and in the domains of the Index of Premature Ejaculation (IPE) over 3 months. Secondary endpoints were captured using the categories in the premature ejaculation profile (PEP). All values are geometric mean when appropriate. RESULTS Data from 256 patients was evaluable. The baseline IELT in both groups was <0.6 min which increased 4.7-fold and 1.5-fold in the PSD502 and placebo groups, respectively (p<0.0001), resulting in a mean IELT of 2.6 min in the PSD502 group. Although fully effective at 1 month, some additional benefit was observed at months 2 and 3. There were greater improvements in all domain scores of the IPE in the PSD502 group compared to placebo resulting in 5.0, 4.6 and 2.5 point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains respectively (p<0.0001 for all). Likewise, all categories in the PEP for both patient and partner were substantially improved by PSD 502 when compared to placebo and baseline. Only 9.6% of patients reported treatment-related adverse events in the PSD502 group and 1.2% in the placebo group; the majority being loss of erection or hypoesthesia. PSD502 was also well tolerated by female partners. No systemic side effects were observed. CONCLUSIONS In this second of two large placebo-controlled phase III studies, PSD502 produced a clinically and statistically significant increase from baseline in IELT, significant improvements in patient- and partner-rated improvement scales and few adverse events when applied 5 min before intercourse. As in earlier studies, significant improvement was apparent in the short term and there was some additional degree of enhancement with time. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e575-e576 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Culley Carson Chapel Hill, NC More articles by this author Ira Sharlip San Francisco, CA More articles by this author Mike Wyllie London, United Kingdom More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.