Pharmacokinetics and safety of long-acting testosterone undecanoate injections in hypogonadal men: an 84-week phase III clinical trial

Journal of Andrology
Christina WangRonald S Swerdloff

Abstract

Currently available testosterone (T) injections in the United States are administered at 2-3 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) intramuscular (IM) injection in hypogonadal men. An unblinded, multicenter phase 3 clinical trial was conducted in 31 academic centers and contract research organizations. Males (130) more than 18 years of age with serum total T < 300 ng/dL were enrolled and received 750-mg injections of TU at weeks 0 and 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 (E(2)) 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 E(2) levels and their ratios to serum T remained relatively consistent once steady state was attained. TU injections were generally well tolerated, with safety profiles si...Continue Reading

Citations

Apr 17, 2012·International Journal of Endocrinology·Prasanth N SurampudiRonald Swerdloff
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