title: Concomitant administration of lumiracoxib and a triphasic oral contraceptive does not affect contraceptive activity or pharmacokinetic profile.
abstract: 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.
authors.affiliation: Department of Exploratory Clinical Development, Novartis Pharma AG, WSJ 210-313, CH-4002, Basel, Switzerland.
authors.forename: Jyoti
authors.initials: J
authors.lastname: Kalbag
authors.forename: Cheryl
authors.initials: C
authors.lastname: Elder
authors.forename: Graham
authors.initials: G
authors.lastname: Scott
authors.forename: Yibin
authors.initials: Y
authors.lastname: Wang
authors.forename: Slavica
authors.initials: S
authors.lastname: Milosavljev
authors.forename: Philipp
authors.initials: P
authors.lastname: Leese
authors.forename: Jacque
authors.initials: J
authors.lastname: Caldwell
authors.forename: Christiane
authors.initials: C
authors.lastname: Rordorf
mesh_terms: 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
chemical_list: 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