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
| Autor: | G D Frentz, R Oakes, J Dean, Geoff Hackett, S Liu, D Sandhu, E Curless, D Savage |
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| Rok vydání: | 1999 |
| Předmět: |
Adult
Male Vasodilator Agents Urology Vasoactive intestinal peptide Priapism Placebo-controlled study Placebo Injections Placebos Phentolamine Double-Blind Method Erectile Dysfunction Humans Medicine Adverse effect Aged Cross-Over Studies Dose-Response Relationship Drug business.industry Middle Aged medicine.disease Crossover study Erectile dysfunction Anesthesia business Vasoactive Intestinal Peptide medicine.drug |
| Zdroj: | International Journal of Impotence Research. 11:91-97 |
| ISSN: | 1476-5489 0955-9930 |
| DOI: | 10.1038/sj.ijir.3900388 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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