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Long-term safety and efficacy of oral phentolamine mesylate (Vasomax®) in men with mild to moderate erectile dysfunction

Abstract

The objectives of this study were to evaluate long-term safety and efficacy of phentolamine mesylate, an orally active, rapid-acting alpha-adrenergic receptor antagonist, for the treatment of men suffering from erectile dysfunction (ED). It was an open-label study involving more than 2000 patients. Men received phentolamine mesylate 40 mg or 80 mg (10 tablets/month) as needed for up to 13 months and self-assessed erectile performance using two validated questionnaires. Treatment with phentolamine mesylate was associated with increases in Erectile Function Domain score of the IIEF, successful vaginal penetrations, and in overall satisfaction. Most adverse events were mild or moderate in severity and consistent with the known pharmacodynamic properties of phentolamine. In conclusion, phentolamine mesylate is safe and effective in the long-term treatment of men with mild to moderate ED.

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Acknowledgements

We acknowledge the study coordinators, nurses, and the following investigators who participated in the Vasomax Study Group: Donald Gleason, Jay Young, Joel Kaufman, Marc Gittelman, Dean Knoll, Mitchell Wiatrak, Glen Wells, Gilberto Brito, Christopher Steidle, Jacques Susset, David Talley, Robert Feldman, Myron Murdock, Stacy Childs; Norman Zinner, Eugene Dula, Steve Koukol, Peter Knapp, Mark Immergut, Jeffrey Snyder, George Kornitzer, Arnold Belker, James Barada, John Byrne, Richard Harris, Gilbert McMahon, David Mobley, Stanley Bloom, Donald Kidd, Kevin Tomera, Steven Lamm.

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Padma-Nathan, H., Goldstein, I., Klimberg, I. et al. Long-term safety and efficacy of oral phentolamine mesylate (Vasomax®) in men with mild to moderate erectile dysfunction. Int J Impot Res 14, 266–270 (2002). https://doi.org/10.1038/sj.ijir.3900885

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