Clinical trial: Study Comparing Emergency Contraception Effectiveness in Women Who Weight ≥ 80 kg (NCT03537768)

Eligibility criteria:
Inclusion Criteria:

          1. Be in good general overall health with no chronic medical conditions that result in
             periodic 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 using
             hormonal contraception.

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

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

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

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

          9. Request emergency contraception within 72 hours (3 days) after unprotected coitus, as
             defined by lack of contraceptive use, condom breakage (including condoms lubricated
             with 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 hours
             prior to enrollment;

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

         13. Give voluntary, written informed consent, and agree to observe all study requirements
             including 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 following
             placement 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, 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. -
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction