Concomitant administration of lumiracoxib and a triphasic oral contraceptive does not affect contraceptive activity or pharmacokinetic profile.

Author(s): Kalbag J, Elder C, Scott G, Wang Y, Milosavljev S, Leese P, Caldwell J, Rordorf C

Affiliation(s): Department of Exploratory Clinical Development, Novartis Pharma AG, WSJ 210-313, CH-4002, Basel, Switzerland.

Publication date & source: 2004-06, J Clin Pharmacol., 44(6):646-54.

Publication type: Clinical Trial; Randomized Controlled Trial

This study evaluated the effect of lumiracoxib on the pharmacokinetics and pharmacodynamics of ethinyl estradiol (EE) and levonorgestrel (LN) in Triphasil-28 (a triphasic oral contraceptive). Females stabilized on Triphasil-28 continued on Triphasil-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-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-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.