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
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
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