Topical prostaglandin E1 SEPA* gel for the treatment of erectile dysfunction

Purpose: We compare the systemic effects, local tolerance and effectiveness of topical gel formulations on the penis containing alprostadil (prostagla ndin E1) plus 5% SEPA versus SEPA alone (placebo) in men with erectile dysf unction. Materials and Methods: Erectile response, skin discomfort and erythema were measured in 48 men with erectile dysfunction secondary to vascular, neurog enic, psychogenic or mixed etiologies in this single-blind, placebo control led trial. Results: Application of prostaglandin E1 gel correlated positively with ere ctile response as 67 to 75% of patients had an erection compared to 17% of controls (p <0.001). Blood pressure and heart rate varied minimally. No ser ious adverse effects were observed in the 48 patients, although the majorit y had skin discomfort. Conclusions: Topical prostaglandin E1 gel applied to the penis appears to b e safe, and facilitates audiovisual and tactile stimulation resulting in an erection when given in a clinic setting. Consequences to the female partne r remain unknown.