The main aim of this double-blind randomized crossover study was to compare the efficacy and safety of alprostadil sterile powder (Caverject®) (PGE(1))in a new sterile powder formulation versus placebo in producing erection in patients with erectile dysfunction. Each patient was treated with 5 or 10 pg PGE(1) and placebo in random order. If the results of the three injections were unsatisfactory, 20 µg PGE(1) was administered in an open fashion. A total of 45 patients were recruited and evaluated; 31/45 patients (68.8%) responded to at least one injection of alprostadil. A dose-response relation was observed during the double-blind phase; the 10-pg dose was effective in 55.5% of patients. The acceptability and tolerability of the preparation, evaluated both clinically and by laboratory tests, was very good. In particular, only four drug-related side effects were observed, three (penile burning, penile pain and pain after injection) after 10 pg and one (hematoma) after 5 µg PGE(1).

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