Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim™, compared to AndroGel®

A two‐period, randomized, complete crossover study was performed to evaluate the pharmacokinetic profiles of Testim™ (AA2500), a new 1% testosterone topical gel formulation, compared to AndroGel®, an already available 1% testosterone topical gel. Twenty‐nine hypogonadal subjects received a single dose (50 mg testosterone) of each formulation seven days apart. Cmax estimates for total testosterone, dihydrotestosterone and free testosterone were greater (30, 19 and 38%, respectively) following the application of Testim™ compared to AndroGel®. Similarly, AUC0−24 estimates for total testosterone, dihydrotestosterone, and free testosterone were greater (30, 11 and 47%, respectively) following the application of Testim™ compared to AndroGel®. Confidence intervals for Cmax and AUC0−24 were not wholly contained within the bioequivalence limits for testosterone, therefore Testim™ and AndroGel® are not bioequivalent with Testim™ providing higher serum levels and greater bioavailability than AndroGel®. Copyright © 2003 John Wiley & Sons, Ltd.