Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg

Exclusion Criteria

• •1. Be currently pregnant (positive high-sensitivity urine pregnancy test);
• •2. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unless the subject has already had a menses following discontinuation of breastfeeding;
• •3. Desire to use hormonal systemic contraception within 5 days of study drug use
• •4. Have had a female sterilization procedure;
• •5. Have a partner with a history of vasectomy;
• •6. Current inability to tolerate oral medication;
• •7. Have impaired hypothalamic-pituitary-adrenal reserve or oral glucocorticoid replacement therapy in the last year.
• •8. Have known liver disease;
• •9. Have known liver abnormalities with elevated enzymes at least twice the upper limit of normal requiring use of liver enzyme inducers.
• •10. Have known hypersensitivity to the active substance UPA or LNG, or any of the excipients of the study treatment.
• •11. Have a current need for exogenous hormones.
• •12. Have concomitant use of strong CYP3A4 inhibitors (as identified by the FDA) or inducers at the time of or planned use within 3 days of dosing;
• •13. Use any medications that can interfere with the metabolism of hormonal contraceptives; take antibiotics that can interfere with metabolism of hormonal contraceptives at the time of or planned use within 3 days of dosing of the study drug; or use any drugs designated by the FDA as falling in the Pregnancy and Lactation narrative subsections (formerly Category D or X medications).
• •14. Current or recent (within one month) participation in any other trial of an investigational medicine or device or planning to participate in another clinical trial during this study.
• •15. Have a history of a bariatric surgery procedure associated with malabsorption.
• •16. Live outside of the catchment area of the study site.
• •17. Have used UPA or LNG EC within 30 days prior to enrollment and not had a menses since using the drug.
• •18. Be a site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities. -