New testosterone buccal system (Striant) delivers physiological testosterone levels: pharmacokinetics study in hypogonadal men.
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.
Wang
Christina
C
Department of Medicine, Harbor-University of California, Los Angeles Medical Center and Research and Education Institute, Torrance, California 90509-2910, USA. wang@gcrc.rei.edu
Swerdloff
Ronald
R
Kipnes
Mark
M
Matsumoto
Alvin M
AM
Dobs
Adrian S
AS
Cunningham
Glenn
G
Katznelson
Laurence
L
Weber
Thomas J
TJ
Friedman
Theodore C
TC
Snyder
Peter
P
Levine
Howard L
HL
D000328:Adult; D000368:Aged; D000375:Aging / Q000097:blood; D000728:Androgens / Q000008:administration & dosage* / Q000097:blood* / Q000493:pharmacokinetics; D015992:Body Mass Index; D002610:Cheek; D013196:Dihydrotestosterone / Q000097:blood; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D004958:Estradiol / Q000097:blood; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007006:Hypogonadism / Q000097:blood* / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D007986:Luteinizing Hormone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa; D009994:Osmolar Concentration; D010342:Patient Acceptance of Health Care; D010349:Patient Compliance; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood* / Q000493:pharmacokinetics; D014014:Tissue Adhesives
D000728:Androgens; D014014:Tissue Adhesives; D013196:Dihydrotestosterone; D013739:Testosterone; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone