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The Effect of Etoricoxib on the Pharmacokinetics of Oral Contraceptives in Healthy Participants

From Merck Research Laboratories, Rahway, New Jersey (Dr Schwartz, Dr Wong, Mr Larson, Ms Crumley, Mr Mehta, Dr Gottesdiener, Dr Agrawal); PPD Development, LP, Austin, Texas (Dr Hunt); and New Orleans Center for Clinical Research, New Orleans, Louisiana (Dr Smith).

The pharmacokinetics of oral contraceptive (OC) components, ethinyl estradiol (EE) and norethindrone (NET), were evaluated after coadministration with etoricoxib in 3 double-blind, randomized, 2-period crossover studies of healthy women. There were 16, 39, and 24 participants enrolled in studies 1 (part I, part II), and 2, respectively. Each participant received triphasic OC (EE 35 µg/NET 0.5 mg x 7 days, 0.75 mg x 7 days, 1.0 mg x 7 days) throughout each 28-day period. OC was coadministered with 21 days of etoricoxib daily followed by placebo for 7 days; the alternate period followed the reverse regimen (placebo to etoricoxib). Study 1 (part I) examined concurrent (morning) administration of OC/etoricoxib 120 mg, study 1 (part II) examined staggered (morning/night) administration of OC/etoricoxib 120 mg, and study 2 examined concurrent (morning) administration of OC/etoricoxib 60 mg. Coadministration of OC and etoricoxib 120 mg once daily was associated with a 50% to 60% increase in EE concentrations, whereas etoricoxib 60 mg once daily was associated with a 37% increase in EE concentrations. Coadministration of OC and etoricoxib was generally well tolerated. A clinically important change in NET AUC_{0-24 h} was not observed. Adverse events included dyspepsia, diarrhea, headache, nausea, fatigue, loss of appetite, and taste disturbance.

Key Words: Etoricoxib • ethinyl estradiol • hormones • NSAIDs • oral contraceptives

Address for reprints: Nancy Agrawal, PhD, Merck Research Laboratories, PO Box 4, Sumneytown Pike, West Point, PA 19486; e-mail: nancy_agrawal{at}merck.com.

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