Eroxon formed part of this double-blind study. 250 subjects using Eroxon were studied in nine Eastern European countries over a 12-week period. Results were assessed over the 12-week period with a minimum of one intercourse attempt per week and compared with the pre-treatment or baseline ED. (Baseline levels were determined over a 4-week run in period where subjects were asked to attempt intercourse at least once per week without the use of any treatment to help their ED). A variety of other measures included onset of action and safety.
What is the set-up of study FM71?
This study was constructed with the advice of the US FDA and was run in three European countries and the United States. 96 patients used either Eroxon or tadalafil 5mg for a 24-week period. Results were assessed at 24 weeks against baseline (determined on the same basis as FM57) along with other measures including onset of action and safety.
Why are there no placebo controlled studies?
Eroxon, was the “placebo” used in FM57 and gave surprising results having efficacy approximately double that normally achieved in ED studies with regular placebos. Moreover, when assessed against internationally accepted criteria for clinical effectiveness (Rosen and Araujo) the efficacy of Eroxon exceeded the minimal clinically important differences (MCID).
Why hasn't a double blind study been conducted?
FM57 was a double-blind study. It was not possible to double-blind FM71 as the two treatment arms were not matched; a topical gel and a tablet. US FDA accepted the “open-label” design proposed by Futura Medical.