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Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men1
Adrian S. Dobs, A. Wayne Meikle, Stefan Arver, Steven W. Sanders, Kim E. Caramelli and Norman A. Mazer
- Author Affiliations

Johns Hopkins Medical Center (A.S.D.), Baltimore, Maryland 21287; Departments of Medicine (A.W.M.) and Pharmaceutics (N.A.M.), University of Utah, Salt Lake City, Utah 84132; Karolinska Hospital (S.A.), Stockholm, Sweden; and TheraTech Inc. (S.W.S., K.E.C., N.A.M.), Salt Lake City, Utah 84108
Address all correspondence and requests for reprints to: Adrian S. Dobs, M.D., M.H.S., Associate Professor and Vice Chair, Department of Medicine, Johns Hopkins University, 1830 East Monument Street, Room 328, Baltimore, Maryland 21205. E-mail: [e-mail].
Abstract

The pharmacokinetics, efficacy, and safety of the Androderm testosterone (T) transdermal system (TTD) and intramuscular T enanthate injections (IM) for the treatment of male hypogonadism were compared in a 24-week multicenter, randomized, parallel-group study. Sixty-six adult hypogonadal men (22–65 years of age) were withdrawn from prior IM treatment for 4–6 weeks and then randomly assigned to treatment with TTD (two 2.5-mg systems applied nightly) or IM (200 mg injected every 2 weeks); there were 33 patients per group. Twenty-six patients in the TTD group and 32 in the IM group completed the study.

TTD treatment produced circadian variations in the levels of total T, bioavailable T, dihydrotestosterone, and estradiol within the normal physiological ranges. IM treatment produced supraphysiological levels of T, bioavailable T, and estradiol (but not dihydrotestosterone) for several days after each injection. Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients (range, 77–100%) than IM patients (range, 19–84%). Both treatments normalized