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Pharmacokinetic Characteristics, Efficacy, and Safety of Buccal Testosterone in Hypogonadal Males: A Pilot Study¹

Department of Medicine, Johns Hopkins University School of Medicine (A.S.D., R.A.), and the Departments of Epidemiology (D.R.H.) and Biostatistics (M.-C.C.), Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland 21205

Address all correspondence and requests for reprints to: Adrian Dobs, M.D., M.H.S., 600 North Wolfe Street, Blalock 906B, Johns Hopkins Hospital, Baltimore, Maryland 21287-4906. E-mail: adobs{at}welchlink.welch.jhu.edu

Transbuccal administration of drugs provides an easy route of administration. To test the safety and efficacy of a novel testosterone (T) product, we performed a randomized, double blind, placebo-controlled study in a parallel design. Men with serum T levels below 250 ng/dL were administered either an active buccal tablet containing 10 mg T (n = 7) or a buccal placebo tablet (n = 6) containing 3 mg pseudoephedrine HCl for taste matching. Men were studied while taking a standard T enanthate dose, after 6 weeks of a wash-out period, and after 8 weeks of therapy. The men were matched for age (mean ± SD, 41 ± 16 vs. 47 ± 16) and type of hypogonadism (three primary testicular failures in each group, with the remainder having a central etiology). Acute pharmacokinetic testing showed peak serum hormone levels at 30 min, with a mean serum T concentration of 2688 ± 147 ng/dL (range, 1820–3770 ng/dL). Levels returned to baseline in 4–6 h, resulting in a total T area under the curve level of 3865 ng/hn·dL, less than that using other available forms of T administration. Similar pharmacokinetics were observed for the hormone’s metabolites, bioavailable T, free T, and estradiol. After 8 weeks of treatment, the results of nocturnal penile tumescence studies evaluating rigidity and circumference were significantly different from those in the placebo group (P < 0.05) and comparable to those during T enanthate therapy. In conclusion, transbuccal T therapy was sufficient to maintain normal sexual function while minimizing the total time of exposure to elevated circulating serum T levels.

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