Alprostadil sterile powder formulation for intracavernous treatment of erectile dysfunction.
The main aim of this double-blind randomized crossover study was to compare the efficacy and safety of alprostadil sterile powder (Caverject) (PGE1) in a new sterile powder formulation versus placebo in producing erection in patients with erectile dysfunction. Each patient was treated with 5 or 10 micrograms PGE1 and placebo in random order. If the results of the three injections were unsatisfactory, 20 micrograms PGE1 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-micrograms 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 micrograms and one (hematoma) after 5 micrograms PGE.
Colli
E
E
Medical Department, Upjohn SpA, Milan, Italy.
Calabrò
A
A
Gentile
V
V
Mirone
V
V
Soli
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000527:Alprostadil / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects / Q000502:physiology; D011208:Powders; D012449:Safety; D013242:Sterilization; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D011208:Powders; D014665:Vasodilator Agents; D000527:Alprostadil