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* To whom correspondence should be addressed. E-mail: wang{at}labiomed.org.
Currently available testosterone (T) injections in the United States are administered at 2 to 3 weekly intervals. Less frequent injections with favorable serum T pharmacokinetics would benefit hypogonadal men. The objective of this study is to assess the pharmacokinetics of long-acting testosterone undecanoate (TU) IM injection in hypogonadal men. An unblinded, multicenter, phase 3 clinical trial was conducted in 31 academic centers and contract research organizations. 130 males over 18 years of age with serum total T < 300 ng/dL were enrolled and received TU 750 mg injections at week 0, 4, and every 10 weeks thereafter for 9 injections over 84 weeks. The main outcome variables were serum total T, free T, dihydrotestosterone (DHT), estradiol (E2) levels and safety parameters. After the first injection patients maintained average trough T concentrations in the adult male range (300-1000 ng/dL or 10.4-34.7 nmol/L) before each injection and at multiple time points measured after the third and fourth injections. Serum free T, DHT and E2 levels and their ratios to serum T remained relatively consistent once steady-state was attained. TU injections were generally well tolerated with safety profiles similar to other T replacement. We conclude that hypogonadal patients treated for 84 weeks with TU 750 mg IM injection every 10 wk demonstrated average concentrations of T, its metabolites (DHT and E2), as well as ratios DHT:T and E2:T, within the adult male reference range at all time points measured. TU injections would be an acceptable alternative to the currently available 2-3 weekly injectables.
Key words: Androgen •
Hormone •
Long acting testosterone injections •
Male Hypogonadism •
Sex Hormone Levels •
Testosterone Replacement
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