Pre- and postnatal development studies of lasofoxifene, a selective estrogen receptor modulator (SERM), in Sprague-Dawley rats

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 71, Issue 3, 2004, Pages 171-184

  Weisenburger, Walter P ^a,b   Hagler, Alan R ^a   Tassinari, Melissa S ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^b PFIZER INC   (United States)

Author keywords

Antiestrogen; Estrogen; Lasofoxifene; Postnatal development; SERM

Indexed keywords

LASOFOXIFENE; SELECTIVE ESTROGEN RECEPTOR MODULATOR;

ADOLESCENT; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BODY TEMPERATURE; BODY WEIGHT; BREAST MILK; CHILDBIRTH; CONTROLLED STUDY; DRUG ACTIVITY; DRUG BLOOD LEVEL; DRUG EFFECT; DYSTOCIA; FEMALE; FETUS; FOOD INTAKE; GESTATIONAL AGE; LACTATION; LEARNING; MATERNAL BEHAVIOR; MEMORY; MOTOR ACTIVITY; NEWBORN; NONHUMAN; ORGANOGENESIS; PASSIVE AVOIDANCE; POSTMENOPAUSE OSTEOPOROSIS; POSTNATAL DEVELOPMENT; PREGNANCY; PRENATAL DEVELOPMENT; PRIORITY JOURNAL; RAT; RAT STRAIN; REPRODUCTION;

ANIMALS; BEHAVIOR, ANIMAL; BODY TEMPERATURE; BODY WEIGHT; DOSE-RESPONSE RELATIONSHIP, DRUG; EMBRYO; EMBRYONIC DEVELOPMENT; ESTROGENS; FEEDING BEHAVIOR; FEMALE; LACTATION; MALE; MATERNAL EXPOSURE; MAZE LEARNING; OSTEOPOROSIS; PARTURITION; PREGNANCY; PREGNANCY, ANIMAL; PRENATAL EXPOSURE DELAYED EFFECTS; PYRROLIDINES; RATS; RATS, SPRAGUE-DAWLEY; REPRODUCTION; RISK; SELECTIVE ESTROGEN RECEPTOR MODULATORS; TETRAHYDRONAPHTHALENES; TIME FACTORS;

ANIMALIA;

EID: 3543068266     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20013     Document Type: Article

References (34)

1. Biegel LB, Flaws JA, Hirshfield AN, O'Connor JC, Elliott GS, Ladics GS, Silbergeld EK, Van Pelt CS, Hurtt ME, Cook JC, Frame SR. 1998. 90-day feeding and one-generation reproduction study in Crl:CD BR rats with 17 beta-estradiol. Toxicol Sci 44:116-142.
2. Brooks EM, Morgan AL, Pierzga, JM, Wladkowski SL, O'Gorman JT, Derr JA, Kenney WL. 1997. Chronic hormone replacement therapy alters thermoregulatory and vasomotor function in postmenopausal women. J App Physiol 83:477-484.
3. Buelke-Sam J, Cohen IR, Wierda D, Griffey KI, Fisher LF, Francis PC. 1998. The selective estrogen receptor modulator, raloxifene: a segment II/III delivery study in rats. Reprod Toxicol 12:271-288.
4. Cappon GD, Horimoto M, Hurtt ME. 2004 Reproductive toxicity assessment of lasofoxifene, a selective estrogen receptor modulator (SERM), in male rats. Birth Defects Res B 71:142-149 (this issue).
5. Cook JC, Johnson L, O'Connor JC, Biegel LB, Krams CH, Frame SR, Hurtt ME. 1998. Effects of dietary 17 beta-estradiol exposure on serum hormone concentrations and testicular parameters in male Crl:CD BR rats. Toxicol Sci 44:155-168.
6. De Voogd T, Nottebohm F. 1981. Gonadal hormones induce dendritic growth in the adult avian brain. Science 214:202-204.
7. Diaz-Veliz G, Soto V, Dussanbat N, Mora S. 1989. Influence of the estrous cycle, ovariectomy and estradiol replacement upon the acquisition of conditioned avoidance responses in rats. Physiol Behav 46:397-401.
8. Dohler KD, Wuttke W. 1975. Changes with age in levels of serum gonadotropins, prolactin, and gonadal steroids in prepubertal male and female rats. Endocrinology 97:898.
9. Finkelstein JA. 1986. Long-term effects of diethylstilbestrol (DES) on genetically obese and non-obese female Zucker rats. Brain Res Bull 17:885-888.
10. Forger NG, Breedlove SM. 1987. Seasonal variation in mammalian striated muscle mass and motoneuron morphology. J Neurobiol 18:155-165.
11. Gould E, Woolley CS, Frankfurt M, McEwen BS. 1990. Gonadal steroids regulate dendritic spine density in hippocampal pyramidal cells in adulthood. J Neurosci 10:1286-1291.
12. Goyal HO, Braden TD, Mansour M, Williams CS, Kamaleldin A, Srivastava KK. 2001. Diethylstilbestrol-treated adult rats with altered epididymal sperm numbers and sperm motility parameters, but without alterations in sperm production and sperm morphology. Biol Repro 64:927-934.
13. Hampson E. 1990. Estrogen-related variations in human spatial and articulatory-motor skills. Psychoneuroendocrinology 15:97-111.
14. Hart JE. 1988. Subacute toxicity of diethylstilboestrol and hexestrol in the female rat, and the effects of clomiphene pretreatment. Food Chem Toxicol 26:227-232.
15. Hollander M, Wolfe D. 1973. Nonparametric statistical methods. New York: Wiley.
16. Ke HZ, Paralkar VM, Grasser WA, Crawford DT, Qi H, Simmons HA, Pirie CM, Chidsey-Frink KL, Owen TA, Smock SL, Chen HK, Jee WSS, Cameron KO, Rosati RL, Brown TA, Dasilva-Jardine P, Thompson DD. 1998. Effects of CP-336, 156, a new, nonsteroidal estrogen agonist/antagonist, on bone, serum cholesterol, uterus, and body composition in rat models. Endocrinology 139:2068-2076.
17. Ke HZ, Qi H, Crawford DT, Chidsey-Frink KL, Simmons HA, Thompson DD. 2000. Lasofoxifene (CP-336,156), a selective estrogen receptor modulator, prevents bone loss induced by aging and orchidectomy in the adult rat. Endocrinology 141:1338-1344.
18. Ke HZ, Qi H, Chidsey-Frink KL, Crawford DT, Thompson DD. 2001. Lasofoxifene (CP-336,156) protects against the age-related changes in bone mass, bone strength, and total serum cholesterol in intact aged male rats. J Bone Miner Res 16:765-773.
19. Korenbrot CC, Huhtaniemi IT, Weiner RW. 1977. Preputial separation as an external sign of pubertal development in the male rat. Biol Reprod 17:298-303.
20. Laudenslager ML, Wilkinson CW, Carlisle HJ, Hammel HT. 1980. Energy balance in ovariectomized rats with and without estrogen replacement. Am J Physiol 238:R400-R405.
21. Meyer G, Ferres-Torres R, Mas M. 1978. The effects of puberty and castration on hippocampal dendritic spines in mice. Brain Res 155:108-112.
22. Miyakawa M, Arai Y. 1987. Synaptic plasticity to estrogen in the lateral septum of adult male and female rats. Brain Res 436:184-188.
23. Murray JF, Baker BI, Levy A, Wilson CA. 2000. The influence of gonadal steroids on pre-pro melanin-concentrating hormone mRNA in female rats. J Neuroendocrinol 12:53-59.
24. O'Keefe J, Nadel L. 1978. The hippocampus as a cognitive map. Oxford: Clarendon.
25. Olton DDS. 1983. Memory functions and the hippocampus. In: Seifert W, editor. The hippocampus. London: Academic. p 335-373.
26. Ozolins TRS, Gupta U. 2004. Embryo/fetal toxicity assessment of lasofoxifene, a selective estrogen receptor modulator (SERM), in rats and rabbits. Birth Defects Res B 71:161-170 (this issue).
27. Rosati RL, Da Silva JP, Cameron KO, Thompson DD, Ke HZ, Toler SM, Brown TA, Pan LC, Ebbinghaus CF, Reinhold AR, Elliott NC, Newhouse BN, Tjoa CM, Sweetnam PM, Cole MJ, Arriola MW, Gauthier JW, Crawford DT, Nickerson DF, Pirie CM, Qi H, Simmons HA, Tkalcevic GT. 1998. Discovery and preclinical pharmacology of a novel, potent, nonsteroidal estrogen receptor agonist/antagonist, CP-336156, a diaryltetrahydronaphthalene. J Med Chem 41:2928-2931.
28. Terry KK, Cappon GD, Hurtt ME, Gupta U. 2004. Reproductive toxicity assessment of lasofoxifene, a selective estrogen receptor modulator (SERM), in female rats. Birth Defects Res B 71:150-160 (this issue).
29. Treinen KA, Rehm S, Wier PJ. 1998. An evaluation of the novel selective estrogen receptor modulator, idoxifene, for effects on reproduction in rats and rabbits. Toxicol Sci 41:199-207.
30. United States Food and Drug Administration. 1994. International Conference on Harmonization: guideline on detection of toxicity to reproduction for medicinal products: availability notice, Federal Register; Part IX, 48746-48752, September 22, 1994.
31. Wallen WJ, Belanger MP, Wittnich C. 2001. Sex hormones and the selective estrogen receptor modulator tamoxifen modulate weekly body weights and food intakes in adolescent and adult rats. J Nutr 131:2351-2357.
32. Williams CL, Meck WH. 1991. The organizational effects of gonadal steroids on sexually dimorphic spatial ability. Psychoneuroendocrinology 16:155-176.
33. Woolley CS, Gould E, Frankfurt M, McEwen BS. 1990. Naturally occurring fluctuation in dendritic spine density on adult hippocampal pyramidal neurons. J Neurosci 10:4035-4039.
34. Woolley CS, McEwen BS. 1992. Estradiol mediates fluctuation in hippocampal synapse density during the estrous cycle in the adult rat. J Neurosci 12:2549-2554.