©© 2009 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology, 10.1177/0091270009337131
The Effect of Etoricoxib on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
Jules Schwartz 1,
Thomas Hunt 2,
William B. Smith 3,
Peggy Wong 1,
Patrick Larson 1,
Tami Crumley 1,
Anish Mehta 1*,
Keith Gottesdiener 1,
and
Nancy Agrawal 1
1 Merck Research Laboratories
2 PPD Development, LP
3 New Orleans Center for Clinical Research
* To whom correspondence should be addressed. E-mail: anish_mehta{at}merck.com.
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Abstract |
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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 AUC0-24 h was not observed. Adverse events included dyspepsia, diarrhea, headache, nausea, fatigue, loss of appetite, and taste disturbance.
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