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Br J Clin Pharmacol. 1994 Oct;38(4):376-80.

Lansoprazole does not affect the bioavailability of oral contraceptives.

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1
Takeda Pharma, Aachen, Germany.

Abstract

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.

PIP:

The research reported in this paper assessed the effects of the proton pump inhibitor lansoprazole on the bioavailability of a low-dose oral contraceptive (OC) containing 0.03 mg ethinyl estradiol (EE) and 0.15 mg levonorgestrel (LNG). Blood plasma concentrations of lansoprazole, EE, LNG, and several hormones were measured following a two-way, cross-over study design. 24 German women in good health were used in this study. All subjects received physical examinations, complete laboratory work-ups, and were found normal. All women received the OC over two complete menstrual cycles from days 1 to 21, with the remaining 7 days being drug-free. 60 mg per day of lansoprazole or a placebo were given for 21 days with the OC. Plasma was assayed by capillary column gas chromatography with mass spectrometry. Urine was also collected and analyzed. The results showed that the 24 women did not experience any significant change or alteration in plasma EE and LNG levels.

PMID:
7833230
PMCID:
PMC1364784
[Indexed for MEDLINE]
Free PMC Article
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