RE: FM53 P2 trial27 Jul 2020 17:23
Volatility, I agree I cannot find anything that says that the P2 trial used Dermasys as the placebo...indeed the nature of the placebo was not mentioned (other than being a gel). I always understood it to be Dermasys but I may have got that from the P3 trial (which we obviously know it was).
PS: P3 trial (FM57) was described in FUM's RNS as: "FM57 is a dose-ranging, multi-centre, randomised, double-blind, placebo-controlled, home use, parallel group clinical trial of topically applied GTN and will recruit approximately 1,000 patients with mild, moderate or severe ED and compare the efficacy of 0.2%, 0.4% and 0.6% GTN doses of MED2002 against that of placebo. "
And of course we know that the 'placebo' used in FM57 was definitely Dermasys (since renamed MED3000). They may have changed the placebo from P2 (FM53) to P3 (FM57) but it is difficult to see why.