In vivo test systems

The rodent prostate hypertrophy test was developed half a century ago (Hershberger and Shipley 1953) and is still used successfully to determine androgen effects in vivo (e.g. Yin et al. 2003b). Chemical substances are administered to immature male rodents (rats) or those from which the testes has been removed. Whether these compounds show the androgen-like effects or not is evaluated by factors such as changes in organ weights as well as by histological inspection. The agonist and antagonist effects of androgens are measured in this model in which after castration and hormone treatment surrogate endpoints are measured in tissues including prostate, seminal vesicle, and levator ani muscle. In addition, to characterise in vivo properties of compounds in more detail, measurement of biochemical markers for anabolic effects (e.g. IGF and GH) or markers demonstrating action on the brain which are involved in feedback-regulation of steroid synthesis (e.g. plasma hormone levels such as LH) can be used.

Furthermore, animal models including a hormone-dependent tumour are available for assessing the antagonist activity of a potential SARM. Using a rat bearing an androgen-dependent prostate tumour (e.g. Dunning rat) the effect of the SARM on the androgen-dependent prostate tumour can be compared to the effect of the SARM on non-tumour tissues (Zaccheo etal. 2000).

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