New testosterone buccal system (Striant) delivers physiological testosterone levels: pharmacokinetics study in hypogonadal men

J Clin Endocrinol Metab. 2004 Aug;89(8):3821-9. doi: 10.1210/jc.2003-031866.


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 5alpha-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 5alpha-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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Aging / blood
  • Androgens / administration & dosage*
  • Androgens / blood*
  • Androgens / pharmacokinetics
  • Body Mass Index
  • Cheek*
  • Dihydrotestosterone / blood
  • Drug Administration Schedule
  • Drug Delivery Systems*
  • Estradiol / blood
  • Follicle Stimulating Hormone / blood
  • Humans
  • Hypogonadism / blood*
  • Hypogonadism / drug therapy*
  • Hypogonadism / pathology
  • Hypogonadism / psychology
  • Luteinizing Hormone / blood
  • Male
  • Middle Aged
  • Mouth Mucosa
  • Osmolar Concentration
  • Patient Acceptance of Health Care
  • Patient Compliance
  • Testosterone / administration & dosage*
  • Testosterone / blood*
  • Testosterone / pharmacokinetics
  • Tissue Adhesives


  • Androgens
  • Tissue Adhesives
  • Dihydrotestosterone
  • Testosterone
  • Estradiol
  • Luteinizing Hormone
  • Follicle Stimulating Hormone