Lansoprazole does not affect the bioavailability of oral contraceptives.
The effects of the proton pump inhibitor lansoprazole on the bioavailability of a low-dose oral contraceptive (OC), containing 0.03 mg ethinyloestradiol (EE) and 0.15 mg levonorgestrel (LNG), were investigated. Twenty-four healthy females (aged 19-35 years; weight 60.6 +/- 7.1 kg) participated in a multiple-dose, placebo-controlled, randomized two-way cross-over study. All subjects received the OC over 2 full menstrual cycles from day 1 to day 21 separated by a drug-free interval of 7 days. Lansoprazole (60 mg day-1) or placebo was coadministered for 3 weeks each. Plasma concentrations of EE and LNG were determined by GC-MS. The 90% confidence intervals for ratios of Cmax and AUC after log transformation of both EE and LNG ranged between 91 and 111%, indicating that lansoprazole did not affect the bioavailability of EE and LNG.
Takeda Pharma, Aachen, Germany.
W
W
Fuchs
R
R
Sennewald
U
U
Klotz
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D003276:Contraceptives, Oral / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004958:Estradiol / Q000097:blood; D004997:Ethinyl Estradiol / Q000097:blood / Q000493:pharmacokinetics; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D005937:Glucaric Acid / Q000652:urine; D006801:Humans; D006854:Hydrocortisone / Q000031:analogs & derivatives / Q000652:urine; D064747:Lansoprazole; D016912:Levonorgestrel / Q000097:blood / Q000493:pharmacokinetics; D007986:Luteinizing Hormone / Q000097:blood; D008597:Menstrual Cycle; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology; D011374:Progesterone / Q000097:blood; D054328:Proton Pump Inhibitors; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D013810:Therapeutic Equivalency
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D003276:Contraceptives, Oral; D054328:Proton Pump Inhibitors; D012738:Sex Hormone-Binding Globulin; D064747:Lansoprazole; D004997:Ethinyl Estradiol; D011374:Progesterone; D004958:Estradiol; C001380:6 beta-hydroxycortisol; D016912:Levonorgestrel; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D009853:Omeprazole; D005937:Glucaric Acid; D006854:Hydrocortisone