Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm

被引:32
|
作者
Halpern, Vera [1 ]
Combes, Stephanie L. [1 ]
Dorflinger, Laneta J. [1 ]
Weiner, Debra H. [1 ]
Archer, David F. [2 ]
机构
[1] FHI 360, Res Triangle Pk, NC 27709 USA
[2] Eastern Virginia Med Sch, Clin Res Ctr, Norfolk, VA 23501 USA
关键词
Depot medroxyprogesterone acetate; Contraception; Subcutaneous; Pharmacokinetics; CONTRACEPTIVE EFFICACY; OVARIAN-FUNCTION; OVULATION; RETURN; DMPA; WOMEN;
D O I
10.1016/j.contraception.2013.07.002
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Background: The abdomen and thigh are recommended injection sites in the label for Depo-SubQ Provera 104 (TM). We evaluated the pharmacokinetic profile of medroxyprogesterone acetate (MPA) following injection of Depo-SubQ Provera 104 in the upper aim, a Preferred injection site in developing countries. Study design: Twenty-six women in Norfolk, VA, received a single injection of Depo-SubQ Provera 104 in the upper arm in this prospective noncomparative study. We measured MPA serum concentrations prior to injection (day 1) and 11 times postinjection (days 2, 4, 8, 14, 30, 44, 60, 74, 91, 104 and 120). Results: Serum MPA levels peaked at 0.953 ng/mL 2-14 days (interquartile range; median=8) after dosing. Mean AUC(0-91) was 45.1 ng.day/mL. Mean MPA levels at days 91, 104 and 120 were 0.427, 0.367 and 0.327 ng/mL, respectively. A total of 15 individual measurements of MPA were below 0.2 ng/mL. All women but one had MPA levels above 0.1 ng/mL on day 91. Conclusions: Injection of Depo-SubQ Provera 104 (TM) in the upper arm provided sufficient MPA levels for contraceptive protection for 3 months (13 weeks). The uptake and metabolism of MPA when injected in the upper arm may be different from the abdomen and thigh. (C) 2014 Elsevier Inc. All rights reserved.
引用
收藏
页码:31 / 35
页数:5
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