Drug-Drug Interaction Studies With Oral Contraceptives: Pharmacokinetic/Pharmacodynamic and Study Design Considerations.

摘要: Oral contraceptives (OCs) are the most widely used form of birth control among women childbearing potential. Knowledge potential drug-drug interactions (DDIs) with OCs becomes imperative to provide information on medication and enable their inclusion in clinical trials, especially if new molecular entity is a teratogen. Although number DDI guidance documents available, they do not recommendations for design conduct OC studies. The evaluation particularly challenging because availability wide variety combinations hormonal contraceptives, different doses ethinyl estradiol, metabolic profiles progestin component. aim this review comprehensively discuss factors be considered such as pharmacokinetics (PK), pharmacodynamics (PD), choice OC, study population vivo In context, pathways OCs, effect enzyme inhibitors inducers, role sex hormone-binding globulin PK progestins, current evidence DDIs, interpretation PD end points reviewed. With emergence tools like physiologically based modeling, decision an can made much more confidence. This provides comprehensive overview various that need designing studies recommends PK-based adequate measures establish drug interaction measurement when there basis interaction.