A double blind, placebo controlled study of intracavernosal vasoactive intestinal polypeptide and phenotolamine mesylate in a novel auto-injector for the treatment of non-psychogenic erectile dysfunction.
Three hundred and four patients with non-psychogenic erectile dysfunction (ED) completed a dose assessment phase with intracavernosal injection utilizing 25 micrograms vasoactive intestinal polypeptide (VIP) combined with phentolamine mesylate 1.0 mg (VIP/P-1) or 2.0 mg (VIP/P-2) in an auto-injector for a response rate of 83.9%. In a sub-group of 183 patients who withdrew from one or more previous ED therapies, 82% responded with an erection suitable for intercourse. One hundred and ninety-five patients were subsequently treated in a placebo controlled phase. 75.1% responded to VIP/P-1, 12% to placebo (P < 0.001); 66.5% responded to VIP/P-2, 10.3% to placebo (P < 0.001), with the median duration of erection of 54 min. The principal adverse event was transient facial flushing in 2770 injections (33.9%). There was no pain post injection and two episodes of priapism (0.05%). Only nine patients withdrew because of adverse events. Over 85% and 95% of patients were satisfied with the drug and auto-injector, respectively. Over 81% of patients and 76% of partners reported an improved quality of life.
Sandhu
D
D
Department of Urology, Leicester General Hospital, UK.
Curless
E
E
Dean
J
J
Hackett
G
G
Liu
S
S
Savage
D
D
Oakes
R
R
Frentz
G
G
D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007267:Injections / Q000379:methods; D008297:Male; D008875:Middle Aged; D010646:Phentolamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010919:Placebos; D014660:Vasoactive Intestinal Peptide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use
D010919:Placebos; D014665:Vasodilator Agents; D014660:Vasoactive Intestinal Peptide; D010646:Phentolamine