Assessment of Circulating Hormones in Regulatory Toxicity Studies II. Male Reproductive Hormones

When test article–related testicular toxicity or Leydig cell tumors are identified in nonclinical studies, the measurement of circulating hormones such as luteinizing hormone, follicle-stimulating hormone, inhibin, testosterone, or prolactin is often considered in order to aid mechanistic investigat...

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Bibliographic Details
Published in:Toxicologic pathology 2012-10, Vol.40 (7), p.1063-1078
Main Authors: Chapin, Robert E., Creasy, Dianne M.
Format: Article
Language:English
Subjects:
Animals
Animals, Laboratory
Biological and medical sciences
Biomarkers - blood
Cynomolgus
Dogs
Follicle Stimulating Hormone - blood
Leydig Cell Tumor - blood
Leydig Cell Tumor - chemically induced
Luteinizing Hormone - blood
Macaca fascicularis
Male
Medical sciences
Prolactin - blood
Rats
Research Design
Species Specificity
Testis - drug effects
Testis - metabolism
Testosterone - blood
Toxicity Tests - methods
Toxicology
Xenobiotics - toxicity
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Summary:When test article–related testicular toxicity or Leydig cell tumors are identified in nonclinical studies, the measurement of circulating hormones such as luteinizing hormone, follicle-stimulating hormone, inhibin, testosterone, or prolactin is often considered in order to aid mechanistic investigations or to identify potential biomarkers in man. Although some hormone levels are relatively constant, others are subject to wide variability owing to pulsatility of secretion, diurnal rhythms, and stress. To avoid being misled, it is important that this variation is factored into any study design that includes hormone measurements. Since all these possibilities start from the pathologist’s reading of the tissue sections, we begin with a review of the morphologic changes that are tied to underlying alterations in hormones. We then provide the reader with basic information and representative hormone data, including coefficients of variation, for the major male reproductive hormones in the three main nonclinical species (rats, dogs, and cynomolgus monkeys). Power and probability tables for rats and dogs allow estimates of the number of animals or samples needed to provide a given likelihood of detecting a hormonal change of a given size. More importantly, we highlight the variability of this process and the real value in readers developing this information at their own site.
ISSN:0192-6233
1533-1601
DOI:10.1177/0192623312443321