title: Utility of Orchidometric Parameters for Assessing Sexual Maturation in Male Cynomolgus Macaques (Macaca fascicularis).
abstract: Testicular volume is one of several parameters that have been used in preclinical toxicology to facilitate the identification of sexually mature male cynomolgus macaques when semen evaluation is unavailable. Furthermore, testicular volume provides additional information to pathologists to aid in the interpretation of microscopic findings. Orchidometry has been proposed as a useful tool for assessing testicular volume. To assess its utility for this purpose, we used orchidometry to measure testicular volume in untreated control male cynomolgus macaques during preclinical toxicology studies. Additional parameters including age, body weight, testicular weight, serum testosterone, and testicular histology were also evaluated. Serum inhibin B and the diameter of histologic testicular sections were assessed to determine whether they might provide any additional corroborative evidence for differentiating stages of sexual maturity in males. Orchidometry was easy to use in sedated or awake macaques and, in combination with testicular histology, enabled the establishment of cut-off values by which sexually mature male cynomolgus macaques can be identified with a high degree of confidence. The relative utility of the parameters examined for discriminating sexually mature and immature males was testicular volume ≥ serum testosterone > body weight > age; for differentiation of sexually mature and peripubertal males the order was testicular volume ≥ body weight > serum testosterone > age. Testicular weight and the diameter of histologic testicular sections provided corroborative information for discriminating stages of sexual maturity. Serum inhibin B was of little value in helping to differentiate the different stages of sexual maturation evaluated in this study.
authors.affiliation: Drug Safety Research and Development (DSRD) Study Management Group, Pfizer Worldwide Research and Development, Groton, Connecticut;, Email: michael.l.mirsky@pfizer.com.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Mirsky
authors.affiliation: DSRD Statistics, Pfizer Worldwide Research and Development, Groton, Connecticut.
authors.forename: Susan
authors.initials: S
authors.lastname: Portugal
authors.affiliation: Comparative Medicine, Pfizer Worldwide Research and Development, Groton, Connecticut; Current affiliation: Nationwide Children's Hospital, Columbus, Ohio.
authors.forename: Harshan
authors.initials: H
authors.lastname: Pisharath
authors.affiliation: Comparative Medicine, Pfizer Worldwide Research and Development, Groton, Connecticut.
authors.forename: Jodi L
authors.initials: JL
authors.lastname: Osowski
authors.affiliation: Drug Safety Research and Development (DSRD) Study Management Group, Pfizer Worldwide Research and Development, Groton, Connecticut.
authors.forename: Laura
authors.initials: L
authors.lastname: Kearney
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000097:blood; D001835:Body Weight; D007265:Inhibins / Q000097:blood; D008252:Macaca fascicularis / Q000033:anatomy & histology / Q000254:growth & development*; D008297:Male; D012741:Sexual Maturation / Q000502:physiology*; D013737:Testis / Q000473:pathology*; D013739:Testosterone / Q000097:blood
chemical_list: D015415:Biomarkers; C422364:inhibin B; D013739:Testosterone; D007265:Inhibins