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Latest clinical data confirms the effectiveness and positive safety profile of Tempe Spray for men with Premature Ejaculation
New data results presented to the 2010 American Urological Association Annual Meeting in San Francisco demonstrated that 536 men suffering Premature Ejaculation and treated with TEMPE Spray 5 minutes before intercourse were able to maintain an erection 5.5 times longer than men who used the placebo spray.
Men from 70 centers in the USA, Canada and Europe with Premature Ejaculation were evaluated with TEMPE spray over a three-month period with 23,000 exposures recorded. Only 5 percent of the men’s sexual partners reported burning sensation in the vulvovaginal area, while 3.1 percent of men reported loss of erection.
TEMPE Spray Phase III
FDA USA Phase III clinical results confirm:
Tempe Spray has met all co-primary endpoints:
Tempe Spray was well tolerated and only a very low incidence of mild penile numbing (<3%) was observed.
Tempe Spray would be the first prescription treatment in the United States for premature ejaculation, upon FDA approval.
Similar positive results confirmed in European Phase III study:
European Phase III study of Tempe Spray for the treatment of premature ejaculation in Europe is completed and met all the goals of its European Phase III trial.
European Phase III clinical results confirm:
The number of patients in the Tempe Spray group who rated the quality of their orgasm as good or very good increased from 20 percent at baseline to 62 percent after treatment. In comparison, the number of placebo-treated patients with this rating decreased from 21 percent to 19 percent.
The Principal Investigator in the study, Prof Wallace Dinsmore, Royal Victoria Hospital, Belfast commented:
Once the results from the US Phase III study become available in the first half of 2009, the data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
Final analyses confirmed that Tempe Spray produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints. The intravaginal ejaculation latency time (IELT) geometric mean for Tempe Spray was 4 minutes compared to 1 (one) minute in placebo (p<0.0001).
There was a 7 point difference between Tempe Spray and placebo in the IPE domain for Ejaculatory Control (p<0.0001) and a 6 point difference between Tempe Spray and placebo in the IPE domain for Sexual Satisfaction (p<0.0001), where a 2 point difference in a 16 point range is considered clinically significant.
There were no serious adverse events and only 2.6% of patients reported treatment-related adverse events in the Tempe Spray group compared with 1% in the placebo. Tempe Spray was well tolerated and there were no systemic adverse events.
Of these adverse events, only one patient who received Tempe Spray (0.5%) reported temporary numbness of the penis, which was described as mild.
The European study was conducted with 300 randomized patients across 32 investigational centers in four countries across Europe. Of these, 268 patients have now been entered into the optional nine-month open-label study.
TEMPE Spray Phase III recruitment programme in the USA is now completed for the treatment of premature ejaculation, marking the final stage of the clinical development for this product.
Plethora Solutions, which funded the study, intends to submit the drug for regulatory approval when it has completed its U.S. trial, expected in the first half of 2009.
Clinical data results confirm:
Researchers from the UK and Netherlands studied 54 men with premature ejaculation, 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.
Before using the spray, the 54 heterosexual men in the study ejaculated, on average, one minute after vaginal penetration.
The men or their partners used a stopwatch to measure the time from vaginal penetration to ejaculation.
A phase II study data show on average, men who got the spray lasted 2.4 times longer than those who got the placebo.
20 TEMPE users and 23 placebo users completed the study and 83 per cent of all users found the spray easy to use.
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.
No adverse effects were found during patient safety checks, which included vital signs, physical findings, electrocardiograms, haematology, biochemistry and urine analysis.
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.
"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.
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