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 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 0