期刊
CONTRACEPTION
卷 83, 期 1, 页码 55-61出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.contraception.2010.06.015
关键词
Pharmacokinetics; Extended-regimen oral contraceptive; Levonorgestrel; Ethinyl estradiol; Hormone accumulation
资金
- Duramed Research, Bala Cynwyd, PA, USA
Background: This study was conducted to evaluate the steady-state blood concentrations and potential accumulation of levonorgestrel (LNG) and ethinyl estradiol (EE) administered for up to 84 days and EE alone for 7 additional days as an extended-regimen 91-day oral contraceptive (OC). Study design: An open-label, single-site study was conducted in 30 healthy female volunteers. Subjects received daily doses of 0.15 mg LNG/0.03 mg EE for 84 consecutive days followed by 0.03 mg EE alone for 7 days. Pharmacokinetic (PK) monitoring was conducted on Days 1, 21, 84 and 91. Results: The observed plasma concentrations of LNG after 84 days and of EE after 84 and 91 days were comparable to the steady-state concentrations observed at 21 days. Pharmacokinetic parameters over the 24-h dosing period were similar at all time points measured after achieving steady-state plasma concentrations. Conclusion: This study demonstrated that an extended-regimen OC providing 84 days of LNG/EE and 7 days of EE alone has a PK profile similar to a 28-day conventional OC regimen and does not result in any additional accumulation of these hormones. (C) 2011 Elsevier Inc. All rights reserved.
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