ACCUTANE NF AND ORAL CONTRACEPTIVE TABLETS IN PREMENOPAUSAL WOMEN W NODULAR ACNE

$0M01FY2000RRNIH

University Of Pennsylvania, Philadelphia PA

Investigators

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Abstract

This is a phase I, multi-center trial. The purpose of this study to determine if Accutane NF alters the pharmacokinetics of ethinyl estradiol and norethindrone. The second purpose is to determine if Accutane NF alters surrogate markers of pharmacodynamic effectiveness of ethinyl estrdiol and norethindrone when used as a oral contraception. Secondary objectives are to describe the single dose pharmacokinetic parameters for isotretinoin and its metabolites when administered as Accutane NF 0.4 mg/kg/day and the steady state pharmacokinetic parameters for isotretinoin and its metabolites when administered as Accutane NF 0.4 mg/kg/day; to assess the overall safety and tolerability of Accutane NF therapy including vital signs, adverse events, and routine laboratory tests during the course of the study.

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