A study in patients with erectile dysfunction comparing different formulations of
prostaglandin E1. Alprostadil Study Group.
Author(s): Vanderschueren D, Heyrman RM, Keogh EJ, Casey RW, Weiske WH, Ogrinc FG, de Koning
Gans HJ.
Affiliation(s): Department of Endocrinology, Catholic University of Leuven, Belgium.
Publication date & source: 1995, J Urol. , 154(5):1744-7
PURPOSE: Prostaglandin E1 sterile powder and sterile solution are 2 new
formulations of exogenous prostaglandin E1 that are more convenient for
auto-injection therapy for erectile dysfunction than the presently used pediatric
sterile solution. Therefore, the pharmacodynamic profiles of intracavernous
prostaglandin E1 sterile powder and nonalcohol sterile solution were compared
with the pediatric sterile solution in men with erectile dysfunction who were
known to be stable responders to intracavernous prostaglandin E1.
MATERIALS AND METHODS: Based on the dose used at home, patients were randomized
to 1 of 5 dose groups: 0 microgram. (placebo), 2.5 micrograms., 5 micrograms., 10
micrograms. or 20 micrograms. Each patient received a single injection of the
same dose of each of the 3 formulations. The primary pharmacodynamic end points
were clinical evaluation of erectile response, RigiScan real-time evaluation of
erectile response and patient evaluation of erectile response.
RESULTS: No significant differences were identified among the formulations for
any of these end points, either by comparison among all active doses or by
comparison at each prostaglandin E1 dose level. There was also little or no
intra-patient variation in dose response and the inter-dose variation in response
between patients was not significant. Pharmacodynamic end points were well
intercorrelated, although assessment of erectile response by the patients tended
to be more positive than that by RigiScan or clinical evaluation. There were no
major side effects. Penile pain on injection and/or during erection occurred in 9
to 17% of the patients according to the formulations. However, penile pain was
also reported by 11% of the placebo-treated patients. CONCLUSIONS;: The 3
formulations of prostaglandin E1 showed equivalence and were safe for the
treatment of erectile dysfunction with respect to side effects.
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