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, Howard L. Levine

Research output: Contribution to journalArticlepeer-review

Abstract

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 5α-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 5α-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.

Original languageEnglish (US)
Pages (from-to)3821-3829
Number of pages9
JournalJournal of Clinical Endocrinology and Metabolism
Volume89
Issue number8
DOIs
StatePublished - Aug 2004

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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