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 (prostaglandin E1) plus 5% SEPA versus SEPA alone (placebo) in men with erectile dysfunction.

Materials And Methods: Erectile response, skin discomfort and erythema were measured in 48 men with erectile dysfunction secondary to vascular, neurogenic, psychogenic or mixed etiologies in this single-blind, placebo controlled trial.

Results: Application of prostaglandin E1 gel correlated positively with erectile 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 serious adverse effects were observed in the 48 patients, although the majority had skin discomfort.

Conclusions: Topical prostaglandin E1 gel applied to the penis appears to be safe, and facilitates audiovisual and tactile stimulation resulting in an erection when given in a clinic setting. Consequences to the female partner remain unknown.