The clinical study will systematically evaluate whether isotretinoin affects the pharmacokinetics of ethinyl estradiol and norethindrone. We will also assess surrogate pharmacodynamic markers for oral contraceptive effectiveness, LH and FSH, to detect whether breakthrough ovulation occurred during the menstrual cycle. Finally, this study will describe the single dose and steady state pharmacokinetics of isotretinoin and its metabolites in these study patients. This is an open label, drug interaction study which will be done in two parts. The study design includes a screening/baseline evaluation followed by the administration of Ortho Novum 7/7/7+ and Accutane + 1.0 mg/kg/day in twice daily divided doses for 16 to 20 weeks. Pharmacokinetic/pharmacodynamic assessments will be made to compare periods with isotretinoin (month 4) to those periods without isotretinoin (month 2). Comparisons will be made both for the low dose phase (day 6) and high dose phase (day 20) of Ortho Novum 7/7/7. A second comparison will be made between single dose (beginning of month 3) and multiple dose isotretinoin pharmacokinetics (month 4, concurrent with hormonal kinetics).
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