Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive

Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive
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DOI:
10.1016/j.contraception.2005.03.005
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发表时间:
2005-09-01
期刊:
影响因子:
2.9
通讯作者:
Kaptein, MCJ
Kaptein, MCJ
中科院分区:
医学3区
文献类型:
--
作者:
van den Heuvel, MW;van Bragt, AJM;Kaptein, MCJ

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这项开放标签、随机研究比较了炔雌醇(EE)的药代动力学,这些药物来自避孕阴道环NuvaRing(15 μ g EE/天)、透皮贴剂(20 μ g EE/天)和含有30 μ g EE的复方口服避孕药(COC)。COC治疗同步2-8周后,受试者被随机分配至21天的NuvaRing、贴剂或COC治疗。21天治疗期间EE浓度-时间曲线下面积(AUQ)分析显示,NuvaRing组的EE暴露量比贴剂组低3.4倍(p <0.05),比药丸组低2.1倍(p <0.05)。受试者的血清EE水平显示NuvaRing的变化远低于贴剂或COC。因此,NuvaRing的EE暴露量显著低于贴片和药丸方法,表明NuvaRing是一种低雌激素剂量的避孕方法,也会导致低雌激素暴露。(c)2005年爱思唯尔公司All rights reserved.
This open-label, randomized study compared the pharmacokinetics of ethinylestradiol (EE) from the contraceptive vaginal ring NuvaRing (15 mu g EE/day), the transdermal patch (20 mu g EE/day) and a combined oral contraceptive (COC) containing 30 mu g EE. After 2-8 weeks of synchronization by COC treatment, subjects were randomized to 21 days of treatment with NuvaRing, patch or COC. Analysis of area under the EE concentration-versus-time curve (AUQ during 21 days of treatment showed that exposure to EE in the NuvaRing group was 3.4 times lower than in the patch group (p < .05) and 2.1 times lower than in the pill group (p < .05). Serum EE levels of subjects showed much lower variation with NuvaRing than with the patch or the COC. Thus, exposure to EE was significantly lower with NuvaRing than with the patch and pill methods, demonstrating that NuvaRing is a low-estrogen-dose contraceptive method that also results in low estrogen exposure. (c) 2005 Elsevier Inc. All rights reserved.