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Topical, Eutectic-Like Mixture Helps Prevent Premature Ejaculation: Presented at CURy

By Chris Berrie

BARCELONA, SPAIN -- February 5, 2008 -- Aerosol application of topically applied eutectic-like mixture for premature ejaculation (TEMPE) is a convenient, safe, well tolerated, on-demand, and efficacious treatment for patients with premature ejaculation, according to a placebo-controlled, phase 2 study presented here at the first World Congress on Controversies in Urology (CURy).

Premature ejaculation is one of the most common sexual problems experienced by men, said Michael G. Wyllie, PhD, Study Designer and Chief Scientific Officer, Plethora Solutions plc, London, England, United Kingdom. "In terms of incidence, prevalence and bother, there are more people who suffer from premature ejaculation than erectile dysfunction," said Dr. Wyllie.

As this condition might arise from abnormal autonomic reflex pathways for the ejaculatory process, including lower penile vibratory threshold, shorter bulbocavernosus latency, and higher bulbocavernosus-evoked potentials, there has been a rationale for the use of local anaesthetics in its treatment.

TEMPE is a formulation aerosol spray dispenses a combination of 7.5 mg lidocaine and 2.5 mg prilocaine, in their base forms, per actuation. It thus delivers a localised application of anaesthetic and is rapidly absorbed by the nonkeratinised skin of the glans penis.

Fifty-four men aged 18 to 75 years and with at least a 6-month history of premature ejaculation were enrolled and randomised to placebo (n = 23) or TEMPE (n = 20), with a treatment comparison arm that was not included in the present analysis.

The primary endpoints were mean change in intravaginal ejaculatory latency time (IELT) from baseline, and proportion of patients responding to treatment (two or more sexual encounters with IELT 4 minutes or more). The secondary endpoints were changes in Index of Ejaculatory Control (IEC) and Sexual Quality of Life Questionnaire (SQoL), the latter for patients and partners.

At baseline, mean IELT were 0.9 and 1.0 minutes for the placebo and TEMPE groups, respectively; at followup, they reached 1.6 and 4.9 minutes, representing improvements from baseline of 0.7 and 3.8 minutes.

Calculation of baseline and centre-adjusted geometric mean changes in the log-transformed data demonstrated a significant 2.4-fold treatment benefit for TEMPE over placebo (2.50 vs 1.04 minutes; P <.01).

The number of responders (IELT 4 or more on two occasions) was also less with placebo (13%) than TEMPE (25%), although the difference did not reach statistical significance. Similarly, there was a trend towards greater benefits for TEMPE over placebo in the number of patients who achieved IELT responses of 2 or more, 3 or more, or 4 or more minutes during at least two sexual encounters.

Finally, the TEMPE group also reported improvements in IEC, and their SQoL scores were improved, according to both partners. However, three patients experienced hypoaesthesia, and one experienced erectile failure on a single occasion.

Thus, this aerosol formulation of TEMPE indeed shows benefits for the patient with premature ejaculation, with approval for its use at present being sought.

Funding for this study was provided by Plethora Solutions plc.


[Presentation title: TEMPE (Topical, Eutectic-Like Mixture for Premature Ejaculation). Poster 29]

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