Fifty-four couples took part in a study to test a new spray for premature ejaculation. The treatment group reported that penetration to ejaculation time increased from an average of one to five minutes with the spray. The placebo group reported an increase of 40 seconds.
Researchers from the UK and Netherlands studied 54 men with premature ejaculation, randomly assigning them to a treatment and control group. Both groups reported that without any therapy they normally ejaculated an average of one minute after vaginal penetration.
“The men who were prescribed the TEMPE spray, which delivers a combination of lidocaine and prilocaine, managed to delay ejaculation by just under an extra four minutes after using the product” reports Professor Wallace Dinsmore from the Royal Victoria Hospital, Belfast.
“Meanwhile the control group, who were prescribed a placebo (dummy) spray, increased their penetration to ejaculation time by just over 40 seconds.
“Overall, the TEMPE spray was 2.4 times more effective than the placebo.”
The study focussed on heterosexual couples who had been in a stable monogamous relationship for at least three months and were willing to attempt sexual intercourse on at least seven occasions during the ten-week study period.
Recruited from six hospitals and medical centres across the UK ? Sheffield, Manchester, Durham, Plymouth, Belfast and London ? and one in The Hague, the men were aged from 18 to 75, with an average age of 39.
Time since diagnosis ranged from seven months to just under 35 years, with an average of nine and a half years.
The men in the TEMPE group (Topical Eutectic Mixture for Premature Ejaculation) administered three metered sprays of the local anaesthetic preparation to the glans of their penis 15 minutes before intercourse. This delivered a total of 22.5mg of lidocaine and 7.5mg of prilocaine.
The placebo group were issued with an identical container that delivered a spray without any active ingredients. Both groups were advised not to use the spray more than once in any 24-hour period to avoid possible bias resulting from too frequent ejaculation.
Participants were also issued with a stopwatch so that they, or their partner, could measure the time lapse between penetration and ejaculation.
20 TEMPE users and 23 placebo users completed the study and 83 per cent of all users found the spray easy to use.
The majority of the TEMPE users and their partners tolerated the spray well. Three men reported numbness in their penis, one said he was unable to get an erection and one partner reported a mild burning sensation each time the spray was used, but continued with the treatment.
No adverse effects were found during patient safety checks, which included vital signs, physical findings, electrocardiograms, haematology, biochemistry and urine analysis.
“At the moment, only a small number of men with premature ejaculation seek or receive treatment from a healthcare professional and the lack of effective pharmacological treatment is a contributory factor” concludes co-author Dr Michael Wyllie from Plethora Solutions Ltd, which manufactures the TEMPE spray.
“The encouraging data from this phase two study suggests that TEMPE has the potential to offer a convenient, novel treatment for men with premature ejaculation and might be useful as a first-line treatment for the condition.”