title: Pharmacokinetics and pharmacodynamics of injectable testosterone undecanoate in castrated cynomolgus monkeys (Macaca fascicularis) are independent of different oil vehicles.
abstract: Testosterone undecanoate (TU) dissolved in soybean oil was developed in China to improve the pharmacokinetics of this testosterone ester in comparison with TU in castor or tea seed oil. As a pre-clinical primate model, three groups of five castrated cynomolgus macaques received either a single intramuscular injection of 10 mg/kg body weight TU in soybean oil, in tea seed oil, or in castor oil (equals 6.3 mg pure T/kg body weight for all preparations). Testosterone, estradiol, luteinizing hormone, and follicle-stimulating hormone as well as prostate volume, body weight and ejaculate weight were evaluated. After injection supraphysiological testosterone levels were induced. There were no significant differences in the pharmacokinetics of the three TU preparations for testosterone and estradiol. The gonadotropin levels showed a high individual variation. Prostate volumes increased equally in all groups after administration and declined to castrate level afterwards. The results suggest that TU in soybean oil produces similar effects as TU in the other vehicles. This study in non-human primates provides no objection to testing of this new preparation in humans.
authors.affiliation: Institute of Reproductive Medicine of the University, Münster, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Wistuba
authors.forename: C
authors.initials: C
authors.lastname: Marc Luetjens
authors.forename: Axel
authors.initials: A
authors.lastname: Kamischke
authors.forename: Yi-Qun
authors.initials: YQ
authors.lastname: Gu
authors.forename: Stefan
authors.initials: S
authors.lastname: Schlatt
authors.forename: Manuela
authors.initials: M
authors.lastname: Simoni
authors.forename: Eberhard
authors.initials: E
authors.lastname: Nieschlag
mesh_terms: D000818:Animals; D001835:Body Weight; D002368:Castor Oil / Q000008:administration & dosage; D004958:Estradiol / Q000097:blood; D005640:Follicle Stimulating Hormone / Q000097:blood; D007273:Injections, Intramuscular; D007986:Luteinizing Hormone / Q000097:blood; D008252:Macaca fascicularis / Q000097:blood / Q000378:metabolism*; D008297:Male; D009919:Orchiectomy; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage; D011467:Prostate / Q000502:physiology; D013024:Soybean Oil / Q000008:administration & dosage; D020947:Tea Tree Oil / Q000008:administration & dosage; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics*
chemical_list: D014677:Pharmaceutical Vehicles; D013739:Testosterone; D004958:Estradiol; D020947:Tea Tree Oil; D013024:Soybean Oil; D002368:Castor Oil; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; C010792:testosterone undecanoate