Document Detail

Pharmacology and toxicology of ethinyl estradiol and norethindrone acetate in experimental animals.
MedLine Citation:
PMID:  11502156     Owner:  NLM     Status:  MEDLINE    
For over 30 years various combinations of synthetic estrogens and progestins have been used in oral contraceptive formulations. Ethinyl estradiol (EE) and norethindrone acetate (NA) are common synthetic hormones used in oral contraceptives such as Loestrin, Brevicon, Ortho-Novum, Norlestrin, and Norinyl. In recent years these oral contraceptives have been considered for development in other therapeutic indications. Given the use of these agents for other clinical indications with different and larger target populations, an updated comprehensive review of the toxicology literature of estrogens and progestins is warranted. This review will summarize available data on the pharmacology and toxicology of estrogens and progestins with an emphasis on the specific synthetic hormones EE and NA. Ethinyl estradiol and norethindrone acetate alone or in combination, possess low acute and chronic toxicity. In some studies, EE and/or NA increased the incidence of specific tumors in susceptible strains of rodents and dogs, but not monkeys. These agents are not teratogenic when given in combination. Alone EE and NA have clastogenic properties. Overall, the animal data demonstrates that long-term exposure to EE and NA formulations pose very little health risks to humans.
W E Maier; J R Herman
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Publication Detail:
Type:  Comparative Study; In Vitro; Journal Article; Review    
Journal Detail:
Title:  Regulatory toxicology and pharmacology : RTP     Volume:  34     ISSN:  0273-2300     ISO Abbreviation:  Regul. Toxicol. Pharmacol.     Publication Date:  2001 Aug 
Date Detail:
Created Date:  2001-08-14     Completed Date:  2001-10-25     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8214983     Medline TA:  Regul Toxicol Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  53-61     Citation Subset:  IM    
Copyright Information:
Copyright 2001 Academic Press.
Drug Safety Evaluation, Pfizer Global Research & Development, 2800 Plymouth Road, Ann Arbor, Michigan 48105, USA.
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MeSH Terms
Animals, Laboratory
Contraceptives, Oral / toxicity*
Dose-Response Relationship, Drug
Drug Combinations
Drug Evaluation, Preclinical
Ethinyl Estradiol / toxicity*
Gonadal Steroid Hormones / physiology
Mutagens / toxicity
Neoplasms / chemically induced
Norethindrone / analogs & derivatives,  toxicity*
Species Specificity
Teratogens / toxicity
Toxicity Tests
Reg. No./Substance:
0/Contraceptives, Oral; 0/Drug Combinations; 0/Gonadal Steroid Hormones; 0/Mutagens; 0/Teratogens; 38673-38-0/norethindrone acetate; 57-63-6/Ethinyl Estradiol; 68-22-4/Norethindrone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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