Abstract：
BACKGROUND:The pharmacokinetics of the monophasic oral contraceptive nomegestrol acetate (NOMAC) plus 17β-estradiol (E(2)) were investigated after a single dose and multiple dosing. STUDY DESIGN:NOMAC/E2 (2.5 mg/1.5 mg) was administered daily to healthy women (18-50 years, n=23) for 24 days; blood samples for pharmacokinetic analysis were obtained on Day 24 and again, after a 10-day pill-free interval, on Day 35 after a single dose. RESULTS:NOMAC reached steady state after 5 days with mean ±standard deviation (SD) trough NOMAC concentration (C(av)) of 4.4±1.4 ng/mL. On Day 24, mean±SD peak NOMAC concentration (Cmax, 12.3±3.5 ng/mL) was reached in mean 1.5 h (t(max)); the mean±SD elimination half-life (t(½)) was 45.9±15.3 h. After a single dose, NOMAC mean±SD C(max) was 7.2±2.0 ng/mL and mean±SD t(½) was 41.9±16.2 h. On Day 24, E2 mean±SD C(av) was 50.3±25.7 pg/mL; mean±SD Cmax was 86.0±51.3 pg/mL. After a single dose, mean±SD E2 Cmax was 253±179 pg/mL. CONCLUSIONS:These data demonstrate that NOMAC/E2 has a pharmacokinetic profile consistent with once-daily dosing.
journal_name
Contraceptionjournal_title
Contraceptionauthors
Gerrits MG,Schnabel PG,Post TM,Peeters PAdoi
10.1016/j.contraception.2012.07.001subject
Has Abstractpub_date
2013-02-01 00:00:00pages
193-200issue
2eissn
0010-7824issn
1879-0518pii
S0010-7824(12)00667-1journal_volume
87pub_type
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