title: Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation.
abstract: OBJECTIVE
  To evaluate, in a phase II study, the efficacy and safety of a topical eutectic mixture for premature ejaculation (TEMPE), a metered-dose aerosol spray containing a eutectic mixture of lidocaine and prilocaine, as a treatment for PE.
  
  
  METHODS
  Men with PE (Diagnostic and Statistical Manual-IV definition) aged 18-75 years were randomized into a double-blind, placebo-controlled study in the UK and the Netherlands. Efficacy variables included the mean change in intravaginal ejaculatory latency time (IELT) from baseline and the proportion of patients who achieved an IELT of > or = 4, > or = 3 or > or = 2 min on two occasions, and the effect of TEMPE on the index of ejaculatory control (IEC) and sexual quality-of-life (SQoL) scores of patients and their partners. Safety and adverse event data were also collected. Fifty-four patients were randomized and received study treatment.
  
  
  RESULTS
  The observed mean change in IELT from baseline to the end of the treatment period was 3.8 min in the TEMPE group and 0.7 min in the placebo group, and when adjusted for baseline and centre was 2.4 times higher in the TEMPE than the placebo group (P < 0.01). The efficacy of TEMPE in increasing IELT was further supported by positive trends in the other efficacy endpoints. The proportion of men who had an IELT time > or = 2, > or = 3 or > or = 4 min on two occasions after treatment was 11/20 (55%), 8/20 (40%) and 5/25 (20%) in the TEMPE group, and 8/23 (35%), 3/23 (13%) and 3/23 (13%) in the placebo group, respectively, although these differences were not statistically significant. Improvements in IEC and SQoL (male and female) scores also showed trends towards greater efficacy for TEMPE than placebo. In all, 35 of 42 (83%) patients considered the spray easy to use. Mild to moderate local numbness occurred in three (12%) of the TEMPE-treated patients but did not lead to discontinuation.
  
  
  CONCLUSIONS
  Topical treatment with TEMPE produced a statistically and clinically significant increase in IELT compared with placebo, and resulted in positive trends in ejaculatory control and SQoL. TEMPE was considered easy to use and was well tolerated. The data support the conduct of further large-scale studies to establish the utility of TEMPE as a first-line treatment for PE.
authors.affiliation: Royal Victoria Hospital, Belfast, UK.
authors.forename: Wallace W
authors.initials: WW
authors.lastname: Dinsmore
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Hackett
authors.forename: David
authors.initials: D
authors.lastname: Goldmeier
authors.forename: Marcel
authors.initials: M
authors.lastname: Waldinger
authors.forename: John
authors.initials: J
authors.lastname: Dean
authors.forename: Patrick
authors.initials: P
authors.lastname: Wright
authors.forename: Michael
authors.initials: M
authors.lastname: Callander
authors.forename: Kevan
authors.initials: K
authors.lastname: Wylie
authors.forename: Claire
authors.initials: C
authors.lastname: Novak
authors.forename: Charlotte
authors.initials: C
authors.lastname: Keywood
authors.forename: Patricia
authors.initials: P
authors.lastname: Heath
authors.forename: Michael
authors.initials: M
authors.lastname: Wyllie
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D004542:Ejaculation / Q000187:drug effects*; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D017060:Patient Satisfaction; D011318:Prilocaine / Q000008:administration & dosage* / Q000009:adverse effects; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000336:Aerosols; D000779:Anesthetics, Local; D011318:Prilocaine; D008012:Lidocaine