Authors: Wistuba, Joachim; Marc Luetjens, C.; Kamischke, Axel¹; Gu, Yi-Qun²; Schlatt, Stefan¹; Simoni, Manuela¹; Nieschlag, Eberhard¹

Source: Journal of Medical Primatology, Volume 34, Number 4, August 2005 , pp. 178-187(10)

Publisher: Wiley-Blackwell

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 bodyweight TU in soybean oil, in tea seed oil, or in castor oil (equals 6.3 mg pure T/kg bodyweight 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.

Keywords: castor oil; macaque; pharmacokinetics; soybean oil; tea seed oil; testosterone undecanoate

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1600-0684.2005.00115.x

Affiliations: 1: Institute of Reproductive Medicine of the University, Münster, Germany 2: National Research Institute for Family Planning, Beijing, China

Publication date: 2005-08-01

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