Abstract
A contraceptive vaginal system (CVS) containing segesterone acetate (SA) and ethinyl estradiol (EE) was approved in the US (2018) for the prevention of pregnancy. The same ring-shaped CVS is used in a 21-days-in/7-days-out regimen for up to 13 cycles. Hormones are metabolized by the cytochrome p450A (CYP3A) system and inhibitors of CYP3A may decrease their metabolism. Physiologically based pharmacokinetic (PK) modeling of SA hepatic clearance predicted that systemic exposure to SA would increase up to 1.6-fold in the presence of a strong CYP3A inhibitor.
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