J Clin Pharmacol
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DRUG INTERACTIONS

Concomitant Administration of Lumiracoxib and a Triphasic Oral Contraceptive Does Not Affect Contraceptive Activity or Pharmacokinetic Profile

Jyoti Kalbag, MS, Cheryl Elder, PharmD, Graham Scott, PhD, Yibin Wang, PhD, Slavica Milosavljev, MS, Philipp Leese, MD, Jacque Caldwell and Christiane Rordorf, MD

From the Departments of Exploratory Clinical Development, Biostatistics, and Bioanalytics, Novartis Pharmaceuticals, East Hanover, New Jersey.

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.

Key Words: Lumiracoxib • Triphasil®-28 • oral contraceptives • pharmacokinetics • pharmacodynamics

Address for reprints: Christiane Rordorf, MD, Department of Exploratory Clinical Development, Novartis Pharma AG, WSJ 210-313, CH-4002, Basel, Switzerland.


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