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Human & Experimental Toxicology
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A review of drug-induced Leydig cell hyperplasia and neoplasia in the rat and some comparisons with man

DE Prentice

Pre-Clinical Safety Consultants Est., 7 Earning Street, Godmanchester, Huntingdon, Cambs. PE18 8JD, UK

AW Meikle

University of Utah, School of Medicine, 50 North Medical Drive, Salt Lake City, Utah 84132, USA

This paper describes control of normal Leydig cell func tion and testosterone production. The macroscopic and histopathological appearances of spontaneous Leydig cell hyperplasias and tumors (LCT) in the rat are reviewed together with their incidence and hormonal status. Drugs which induce LCTs in chronic studies are discussed and include busereline, carbamazepine, cimetidine, finas teride, flutamide, gemfibrozil, histrelin, hydralazine, indomethacin, isradipine, lactitol, leuprolide, metronida zole, mesulergine, nafarelin, norprolac and vidarabine.

The known mechanisms of LCT induction in the rat are reviewed together with other possible etiological factors. The incidence, clinical picture and etiological factors of LCTs in man are also surveyed. Hormone production in Leydig cells and LCTs in rats and man are compared. Differences between the two species are considered, par ticularly with regard to Leydig cell control mechanisms. The paper concludes that drug-induced LCTs in rats are most probably not predictive for man and their occurrence has little relevance in human safety assessment.

Key Words: Leydig cell tumors • testosterone • rat • man

Human & Experimental Toxicology, Vol. 14, No. 7, 562-572 (1995)
DOI: 10.1177/096032719501400703
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