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

Inclusion Criteria:

1. Be in good general overall health with no chronic medical conditions that result inperiodic exacerbations that require significant medical care.

2. Between 18 and 40 years inclusive at the enrollment visit.

3. Weight ≥ 80 kg.

4. Have regular menstrual cycles that typically occur every 21-35 days when not usinghormonal contraception.

5. If subject is postpartum or post-abortal, she must have experienced a menstrual bleedsince the pregnancy ended

6. If a subject recently used non-injectable hormonal contraception, one bleeding episodeconsistent with menses must have occurred since last use;

7. Willing to avoid use of any hormonal or intrauterine contraception until the end ofthe study;

8. For women with a recent history of Depo Provera use, the most recent injection musthave been at least 6 months before study entry, and the subject must have had at leastone normal menstrual cycle (2 consecutive menses);

9. Request emergency contraception within 72 hours (3 days) after unprotected coitus, asdefined by lack of contraceptive use, condom breakage (including condoms lubricatedwith spermicide), or other barrier contraceptive method failure;

10. Have a negative urine pregnancy test at time of screening

11. Reports all acts of unprotected coitus since her prior menses are within 72 hoursprior to enrollment;

12. Willing to abstain from further acts of unprotected intercourse until the end of thestudy;

13. Give voluntary, written informed consent, and agree to observe all study requirementsincluding being available for follow up for at least the next 4 weeks;

14. Accepts that the risk of pregnancy with oral EC is greater than that followingplacement of a copper IUD for EC.

Exclusion Criteria:

1. Be currently pregnant (positive high-sensitivity urine pregnancy test);

2. Be currently breastfeeding or within 30 days of discontinuing breastfeeding, unlessthe 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 glucocorticoidreplacement therapy in the last year.

8. Have known liver disease;

9. Have known liver abnormalities with elevated enzymes at least twice the upper limit ofnormal requiring use of liver enzyme inducers.

10. Have known hypersensitivity to the active substance UPA or LNG, or any of theexcipients 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) orinducers 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 thetime of or planned use within 3 days of dosing of the study drug; or use any drugsdesignated 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 aninvestigational medicine or device or planning to participate in another clinicaltrial 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 sinceusing the drug.

18. Be a site staff member with delegated study responsibilities or a family member of asite staff member with delegated study responsibilities. -