Steady-state pharmacokinetics of conjugated equine estrogens in healthy, postmenopausal women

J Reprod Med. 2008 Feb;53(2):97-101.

Abstract

Objective: To determine the steady-state exposure of conjugated and unconjugated estrogen components following oral administration of conjugated equine estrogens (2 0.625-mg tablets).

Study design: A prospective, open-label, single-treatment study conducted at 1 clinical site with 12 healthy, postmenopausal women. Each subject received 7 daily doses of 2 conjugated equine estrogen (0.625-mg) tablets, and blood samples were taken on the last day of dosing for pharmacokinetic analysis of estrogen components.

Results: The major estrogen components after estrogen dosing (as determined by steady-state plasma concentration-time curves) were estrone (100 ng x h/mL), equilin (43.1 ng x h/mL) and delta8,9-dehydroestrone (13.6 ng x h/mL). Several 17beta-reduced forms of estrogen also had consistent plasma concentrations during a steady-state dosing interval. Mean t(max) values ranged from 6.2 to 9.0 hours after dosing, and the 24-hour profiles of the various plasma estrogen concentrations at steady state showed limited fluctuations.

Conclusion: Oral dosing of conjugated equine estrogen at steady state resulted in consistent concentrations of estrogen components during a dosing interval.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Estrogens / administration & dosage
  • Estrogens / blood
  • Estrogens / pharmacokinetics*
  • Estrogens, Conjugated (USP) / administration & dosage
  • Estrogens, Conjugated (USP) / blood
  • Estrogens, Conjugated (USP) / pharmacokinetics*
  • Female
  • Humans
  • Middle Aged
  • Postmenopause / drug effects*

Substances

  • Estrogens
  • Estrogens, Conjugated (USP)