三种激素避孕制剂中炔雌醇药代动力学的比较：阴道环、透皮贴剂和口服避孕药。

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

作者信息

van den Heuvel Michiel Wilhelmus, van Bragt Antoinetta Jacoba Maria, Alnabawy Ali Kafi Mohammed, Kaptein Marc Carel John

机构信息

Department of Clinical Pharmacology and Kinetics, NV Organon, PO Box 20, 5340 BH Oss, The Netherlands.

出版信息

Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.

DOI:10.1016/j.contraception.2005.03.005

PMID:16102549

Abstract

This open-label, randomized study compared the pharmacokinetics of ethinylestradiol (EE) from the contraceptive vaginal ring NuvaRing (15 microg EE/day), the transdermal patch (20 microg EE/day) and a combined oral contraceptive (COC) containing 30 microg 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 (AUC) 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.

摘要

这项开放标签的随机研究比较了避孕药阴道环NuvaRing（炔雌醇15微克/天）、透皮贴片（炔雌醇20微克/天）和含30微克炔雌醇的复方口服避孕药（COC）的药代动力学。在通过COC治疗同步2至8周后，受试者被随机分配接受NuvaRing、贴片或COC治疗21天。对治疗21天期间炔雌醇浓度-时间曲线下面积（AUC）的分析表明，NuvaRing组中炔雌醇的暴露量比贴片组低3.4倍（p < 0.05），比药丸组低2.1倍（p < 0.05）。与贴片或COC相比，使用NuvaRing的受试者血清炔雌醇水平变化要低得多。因此，NuvaRing的炔雌醇暴露量明显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，其雌激素暴露量也较低。