Multiple-dose pharmacokinetics of a contraceptive patch in healthy women participants
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- 作者：Abrams ; Larry S. ; Skee ; Donna M. ; Natarajan ; Jaya ; Wong ; Frankie A. ; Lasseter ; Kenneth C.
- 关键词：ORTHO EVRA ; EVRA ; Pharmacokinetics ; Ethinyl estradiol ; Norelgestromin
- 刊名：Contraception
- 出版年：2001
- 出版时间：November, 2001
- 年：2001
- 卷：64
- 期：5
- 页码：287-294
- 全文大小：110 K
文摘
This open-label, randomized study evaluated the pharmacokinetics of norelgestromin (NGMN) and ethinyl estradiol (EE) following the application of a contraceptive patch (1/week) for three cycles (3 weeks/cycle). Healthy women (n = 24) wore a 20-cm2 patch (ORTHO EVRA/EVRA) on either their abdomen or buttock during blood sampling weeks and on any of four approved sites at other times. Serum was analyzed for NGMN and EE from samples taken during Week 1 of Cycle 1 and Weeks 1–3 of Cycle 3. Steady-state conditions were achieved during the three-cycle study. The patch delivered NGMN and EE at steady-state concentrations within their reference ranges throughout three cycles of treatment; reference ranges are based on studies with ORTHO-CYCLEN/Cilest. Steady-state serum concentrations and area under the curve from 0 to 168 h increased only slightly from Cycle 1, Week 1 to Cycle 3, Week 3 for NGMN and EE, indicating minimal accumulation. Treatment was well tolerated, and patch adhesion was excellent.