The efficacy and safety of a topical alprostadil cream, Alprox-TD®, for the treatment of erectile dysfunction: two phase 2 studies in mild-to-moderate and severe ED

Abstract

In two multicenter, placebo controlled, phase 2 studies, patients with mild-to-moderate (n ¼ 161, Study 1) or severe (n ¼ 142, Study 2) erectile dysfunction (ED) were randomized to receive placebo, 0.05, 0.1, or 0.2 mg (Study 1) or placebo, 0.1, 0.2, or 0.3 mg (Study 2) of topically applied alprostadil (containing a proprietary skin permeation enhancer). The primary efficacy end point in both studies was the change in erectile function (EF) score from baseline to final visit. The changes from baseline for EF scores were À0.8 7 1.1, 1.8 7 1.1, 0.7 7 1.2, and 3.7 7 1.2 (Po0.01; Study 1) and 2.7 7 1.3, 6.29 7 1.4, 6.49 7 1.5, and 9.44 7 1.5 (Po0.001; Study 2) for ascending dose groups in each study. Topical alprostadil was well tolerated with the most common adverse event being urogenital pain. These results suggest this topical alprostadil formulation may be a potentially useful agent for the treatment of ED.

Therapie der erektilen Dysfunktion im Jahr 2005

“…Betrachtet man die Ergebnisse der beiden publizierten Studien so bleibt insbesondere unklar, warum Patienten mit schwerer ED besser abschnitten als solche mit leicht bis mäßiger ED [20]. Betrachtet man die GAQ-Raten (global assessment question: Wurde die ED durch die Therapie gebessert?…”

Alprostadil in cream — a new option of treating erectile dysfunctions in diabetic patients

“…The vast majority (97%) of side effects observed in studies was characterised by low intensity and short duration not exceeding 60 minutes [34][35][36][37][38][39][40]. Almost all the side effects limited to the site of administration of the cream and they mostly included: burning of the penis (23%), redness of the glans (11.3%), and balanitis (4.6%) [38].…”

Retention and migration of alprostadil cream applied topically to the glans meatus for erectile dysfunction

“…In these trials, adverse events, which were localized to the application site, were transient and mild to moderate in intensity. 9,10 The safety and efficacy of alprostadil transdermal cream and its role in the treatment of ED will be better defined by the findings of two recently completed phase III clinical trials.…”

“…16 Moreover, the efficacy of topically applied alprostadil in humans has been established in several clinical trials. 9,10,17 The formulation evaluated in this study is designed to be used easily and conveniently by just dripping the cream onto the glans meatus where it is largely retained, allowing local absorption of the active ingredient.…”

“…9,10 Compared with patients given placebo, those given alprostadil transdermal cream showed significant improvement in several critical measures of erectile function. The treatment was also safe and well tolerated, with mild adverse effects limited to the area of application.…”