ALPROSTADIL STERILE POWDER FORMULATION FOR INTRACAVERNOUS TREATMENT OF ERECTILE DYSFUNCTION

The main aim of this double-blind randomized crossover study was to co mpare the efficacy and safety of alprostadil sterile powder (Caverject (R)) (PGE(1)) in a new sterile powder formulation versus placebo in pr oducing erection in patients with erectile dysfunction. Each patient w as treated with 5 or 10 mu g PGE(1) and placebo in random order. If th e results of the three injections were unsatisfactory, 20 mu g PGE(1) was administered in an open fashion. A total of 45 patients were recru ited and evaluated; 31/45 patients (68.8%) responded to at least one i njection of alprostadil. A dose-response relation was observed during the double-blind phase; the 10-mu g dose was effective in 55.5% of pat ients. The acceptability and tolerability of the preparation, evaluate d both clinically and by laboratory tests, was very good. In particula r, only four drug-related side effects were observed, three (penile bu rning, penile pain and pain after injection) after 10 mu g and one (he matoma) after 5 mu g PGE(1).