Abstract

MED2005 is a glyceryl trinitrate (GTN) topical gel with an enhanced absorption delivery system, applied to the glans penis by the male or his partner for treatment of erectile dysfunction (ED). A previous study1 reported the safety and efficacy of 0.2% (0.6mg) GTN MED2005 in 231 patients. Efficacy was primarily seen in patients with mild ED, therefore further studies investigating the safety and efficacy of higher doses of MED2005 are required. To demonstrate similar or lower bioavailability of GTN when administered via MED2005 compared with Nitrostat (1.8mg GTN) at doses up to 0.8% (2.4mg) GTN. 30 healthy male volunteers applied a single topical dose of MED2005 to the glans penis at concentrations of 0.2% (0.6mg), 0.4% (1.2mg), 0.6% (1.8mg) and 0.8% (2.4mg) GTN as well as being administered sublingual Nitrostat (1.8mg) as a reference product, using a crossover study design. Concentrations of GTN and its metabolites were measured in plasma samples using tandem mass spectrometry. In an extension study to measure gel absorption, penile swabs were taken from 10 participants, 5 minutes after application of 0.8% (2.4mg) GTN gel in order to measure residual GTN.

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