Concomitant administration of lumiracoxib and a triphasic oral contraceptive does not affect contraceptive activity or pharmacokinetic profile
Kalbag, J.; Elder, C.; Scott, G.; Wang, Y.; Milosavljev, S.; Leese, P.; Caldwell, J.; Rordorf, C.
Journal of Clinical Pharmacology 44(6): 646-654
2004
ISSN/ISBN: 0091-2700 PMID: 15145973 DOI: 10.1177/0091270004265363Document Number: 390263
This study evaluated the effect of lumiracoxib on the pharmacokinetics and pharmacodynamics of ethinyl estradiol (EE) and levonorgestrel (LN) in Triphasil(R)-28 (a triphasic oral contraceptive). Females stabilized on Triphasil(R)-28 continued on Triphasil(R)-28 alone for another month (Treatment Period 1), then also received lumiracoxib (400 mg daily) or placebo for 28 days each (Periods 2 and 3) in a double-blind crossover design. Plasma pharmacokinetic profiles were assessed on Day 21 of Periods 2 and 3. Progesterone and plasma sex hormone binding globulin (SHBG) concentrations were measured before and 2 hours after Triphasil(R)-28 administration on Day 21 of all three treatment periods. Lumiracoxib had no significant effect on EE or LN pharmacokinetics or on progesterone or SHBG concentrations, indicating that anovulation and Triphasil(R)-28 effectiveness was maintained. Adverse events were similar for lumiracoxib and placebo. Therefore, no clinically important consequences are anticipated if lumiracoxib is coadministered with oral contraceptives containing EE or LN.