Concomitant administration of lumiracoxib and a triphasic oral contraceptive does not affect contraceptive activity or pharmacokinetic profile.
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.
Kalbag
Jyoti
J
Department of Exploratory Clinical Development, Novartis Pharma AG, WSJ 210-313, CH-4002, Basel, Switzerland.
Elder
Cheryl
C
Scott
Graham
G
Wang
Yibin
Y
Milosavljev
Slavica
S
Leese
Philipp
P
Caldwell
Jacque
J
Rordorf
Christiane
C
D000293:Adolescent; D000328:Adult; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D018592:Cross-Over Studies; D051546:Cyclooxygenase 2; D004008:Diclofenac / Q000031:analogs & derivatives; D004311:Double-Blind Method; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D008565:Membrane Proteins; D009930:Organic Chemicals / Q000494:pharmacology*; D011374:Progesterone / Q000097:blood; D011451:Prostaglandin-Endoperoxide Synthases; D012738:Sex Hormone-Binding Globulin / Q000032:analysis
D003277:Contraceptives, Oral, Combined; D007527:Isoenzymes; D008565:Membrane Proteins; D009930:Organic Chemicals; D012738:Sex Hormone-Binding Globulin; D004008:Diclofenac; D011374:Progesterone; D019304:Ethinyl Estradiol-Norgestrel Combination; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; C473384:lumiracoxib