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Phase II clinical results:

Topical Alprostadil Gel Can Improve Erectile Function

[Note: Drugs in clinical trials are not available on the market. This is provided to show the direction of on-going research.]

WESTPORT, CT (Reuters Health) Mar 14 - Alprostadil (prostaglandin E1) combined with a soft enhancer of percutaneous absorption (SEPA) is effective when applied to the glans penis in the treatment of erectile dysfunction in nearly 40% of men, according to the results of an in-office, phase II clinical study.

The findings support further research on the gel, 1% alprostadil (Topiglan), as a potential first-line treatment for erectile dysfunction, study director, Dr. Irwin Goldstein of Boston and colleagues say in the February issue of Urology.

The investigators examined the safety and efficacy of 1% alprostadil gel in an in-office, randomized study including 60 men with moderate to severe erectile dysfunction. After randomization to either 1% alprostadil or placebo gel, men applied the gel to the glans penis only. Thirty minutes later, the men viewed a heterosexual erotic video and applied penile vibration, with monitoring for up to 90 minutes after application.

Men demonstrated greater erectile responses to 1% alprostadil than to placebo at all time points, particularly between 45 and 60 minutes after application. Of the 31 men treated with the active gel, 12 (38.9%) achieved an erection judged sufficient for vaginal penetration. Two of the 29 patients (6.9%) in the placebo group had such a response. While men randomized to 1% alprostadil were more likely than controls to report minor local erythema [reddening of the skin], in most cases this side effect was characterized as "minimal," the authors say. No clinically significant changes in vital signs were noted in men who received the active gel, in contrast to a prior study in which 1% alprostadil was applied to the entire penis.

Urology 2001;57:301-305.

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