Testosterone Pharmacokinetics after Application of an Investigational Transdermal System in Hypogonadal Men

This open‐label, randomized, placebo lead‐in, three‐treatment crossover study in 19 hypogonadal men (27–82 years of age) evaluated dose proportionality of serum testosterone concentrations with application of one or two investigational transdermal testosterone systems for application to the arm or t...

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Bibliographic Details
Published in:Journal of clinical pharmacology 1997-12, Vol.37 (12), p.1139-1145
Main Authors: Yu, Zhiling, Gupta, Suneel K., Hwang, Stephen S., Kipnes, Mark S., Mooradian, Arshag D., Snyder, Peter J., Atkinson, Linda E.
Format: Article
Language:English
Subjects:
Administration, Cutaneous
Adult
Aged
Aged, 80 and over
Biological and medical sciences
Cross-Over Studies
General pharmacology
Hormones. Endocrine system
Humans
Hypogonadism - blood
Male
Medical sciences
Middle Aged
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Skin - metabolism
Testosterone - blood
Testosterone - pharmacokinetics
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Summary:This open‐label, randomized, placebo lead‐in, three‐treatment crossover study in 19 hypogonadal men (27–82 years of age) evaluated dose proportionality of serum testosterone concentrations with application of one or two investigational transdermal testosterone systems for application to the arm or torso. Testosterone in vivo kinetics profiles were determined using DeMonS, a recently developed numerical deconvolution method that estimates drug absorption at different time intervals and/or drug disposition model parameters. After application of the investigational transdermal systems, the mean serum testosterone, dihydrotestosterone, estradiol, and free testosterone concentrations were elevated to normal levels. Treatment allowed approximation of the normal circadian pattern of endogenous testosterone secretion, and the increase in serum testosterone concentrations was proportional to the surface area of systems applied. The investigational transdermal system provided effective testosterone replacement therapy as judged by pharmacokinetic parameters.
ISSN:0091-2700
1552-4604
DOI:10.1002/j.1552-4604.1997.tb04298.x