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The Journal of Clinical Endocrinology & Metabolism Vol. 89, No. 8 3821-3829
Copyright © 2004 by The Endocrine Society

New Testosterone Buccal System (Striant) Delivers Physiological Testosterone Levels: Pharmacokinetics Study in Hypogonadal Men

Christina Wang, Ronald Swerdloff, Mark Kipnes, Alvin M. Matsumoto, Adrian S. Dobs, Glenn Cunningham, Laurence Katznelson, Thomas J. Weber, Theodore C. Friedman, Peter Snyder and Howard L. Levine

Department of Medicine (C.W., R.S.), Harbor-University of California, Los Angeles Medical Center and Research and Education Institute, Torrance, California 90509-2910; Diabetes and Glandular Disease Research Associates (M.K.), San Antonio, Texas 78229-3894; Department of Medicine (A.M.M.), University of Washington, Geriatric Research, Education, and Clinical Center, Veterans Affairs Puget Sound Health Care System, Seattle, Washington 98195; Department of Medicine (A.S.D.), Johns Hopkins University, Baltimore, Maryland 21287-4904; Department of Medicine (G.C.), Baylor University School of Medicine, Houston, Texas 77030; Department of Medicine (L.K.), Massachusetts General Hospital, Boston, Massachusetts 02114; Department of Medicine (T.J.W.), Duke University Medical Center, Durham, North Carolina 27705; Division of Endocrinology (T.C.F.), Department of Medicine, Charles Drew University of Medicine, Los Angeles, California 90059; Department of Medicine (P.S.), University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104-6087; and Columbia Laboratories, Inc. (H.L.L.), Livingston, New Jersey 07039

Address all correspondence and requests for reprints to: Dr. Christina Wang, General Clinical Research Center Box 16, Harbor-University of California Los Angeles Medical Center, 1000 West Carson Street, Torrance, California 90509. E-mail: wang{at}gcrc.rei.edu.

A new mucoadhesive testosterone buccal system (Striant), 30 mg testosterone (T), was applied twice daily in 82 hypogonadal men for 3 months. Serum T, free T, and 5{alpha}-dihydrotestosterone were measured during this period. T pharmacokinetics were determined from the data obtained during a 24-h sampling at wk 12. Physiological mean serum T concentrations were steady and consistently maintained. The mean percentage of time over a 24-h period that total serum T concentrations were above the lower limit of adult male range was 80.1%. During treatment, mean serum 5{alpha}-dihydrotestosterone, free T, and estradiol concentrations paralleled serum T. T pharmacokinetics were not significantly affected by body mass index, age, food or beverage, gum abnormalities, or medications known to cause dry mouth. Gum-related adverse events occurred in 16.3% of subjects. Except for three subjects, the gum adverse effects occurred early during treatment, did not cause interruption of treatment, and resolved rapidly and completely. The T buccal system is a novel T formulation that offers a safe, effective, and convenient alternative to existing formulations for physiological T replacement therapy in hypogonadal men.

This work was supported by Columbia Laboratories, Inc. (Livingston, NJ) and General Clinical Research Center at Harbor-University of California Los Angeles Medical Center (MO1RR00425).

This work was presented in part at the 84th Annual Meeting of The Endocrine Society, San Francisco, California, June, 2002.

Abbreviations: AUC, Area under the curve; BMI, body mass index; Cavg, average serum T levels over a 24-h period; CV, coefficient of variation; DHT, dihydrotestosterone; E2, estradiol; PK, pharmacokinetics; T, testosterone; TBS, T buccal system.




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