Topical alprostadil cream for the treatment of erectile dysfunction: a combined analysis of the phase II program

• Published in: Urology (Ridgewood, N.J.) N.J.), 2002-12, Vol.60 (6), p.1077-1082
• Main Authors: Steidle, Christopher, Padma-Nathan, Harin, Salem, Shawki, Tayse, Natalie, Thwing, Denise, Fendl, Jane, Yeager, James, Harning, Ronald
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adult; Aged; Alprostadil - administration & dosage; Analysis of Variance; Biological and medical sciences; Clinical Trials, Phase II as Topic; Erectile Dysfunction - drug therapy; Erectile Dysfunction - etiology; Genital system. Reproduction; Humans; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Vasodilator Agents - administration & dosage
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(02)01980-5

To present a meta-analysis of the efficacy and safety data of two recently completed Phase II studies examining a novel alprostadil topical cream for the treatment of erectile dysfunction (ED). Patients (n = 303) with ED of at least 3 months’ duration were randomized to receive placebo or 50, 100, 200, or 300 μg alprostadil in two nearly identical 11-dose, multicenter, at-home studies of a novel topical cream containing alprostadil and a proprietary skin permeation enhancer. The primary efficacy endpoint was the change in erectile function domain score from baseline to the final visit. Secondary endpoints included changes in scores for questions 3 and 4 of the International Index of Erectile Function and standard diary analyses. Safety was assessed by analysis of adverse events, changes in laboratory test results, and physical examination findings. The mean baseline parameters for the erectile function score, ED history, and secondary diagnoses suggested no significant differences among the treatment groups. The changes from baseline to the final visit erectile function scores were 0.98 ± 0.84, 3.4 ± 1.3, 3.4 ± 0.88 ( P