Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles

Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles

Inclusion Criteria: 1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age with no upper age limit. Post-menarcheal female subjects who are at risk of pregnancy, and \20 years' duration. 11. Has inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are at increased risk for VTE 12. Medically treated or presence of symptomatic gall bladder disease. 13. History of combined hormonal contraceptive/pregnancy-related cholestasis/jaundice. 14. Presence of liver disease. 15. History of organ transplantation within 5 years before screening or chronic disease potentially necessitating organ transplantation during the anticipated course of the study. 16. Subject has requirement to be on treatment with medications prohibited during study. 12. Known or suspected estrogen or progestin sensitive malignant or premalignant conditions. 13. History of any other condition that in the Investigator's opinion suggests an elevated risk of arterial or venous thromboembolic disease. 14. Has uncontrolled thyroid disorder. 15. Has diagnosis of hereditary angioedema. 16. Has hyperlipidemia on screening. 17. Has uncontrolled diabetes mellitus. 18. Subjects with abnormal significant liver function tests. 19. Has a significantly abnormal cervical cancer screening test (cervical cytology with reflex human-papilloma-virus (HPV) testing or with HPV co-testing) performed at screening visit (for subjects aged ≥21 years) i.e., cervical dysplasia or invasive cervical cancer or has any abnormal cytology with/without HPV testing during 6 months prior to screening which may require additional screening or treatment during the study period 20. Subjects with chlamydial or gonorrheal infection. 21. Has unexplained vaginal bleeding. 22. History of known or suspected hepatitis B or C infection or high risk for sexually transmitted disease (STD). 23. Known human immunodeficiency virus (HIV) infection or positive confirmatory test at screening. 24. Current known active infection of coronavirus disease 2019 (COVID-19) or increased risk of COVID-19 related morbidity. Subjects who have had previous COVID-19 infections but have recovered by the time of enrollment visit may be enrolled if there are no current COVID-19 symptoms; Subjects who had previously received COVID-19 vaccine may be enrolled irrespective of the timing of the vaccination. 25. Within the past year, either history of suicidal ideation or attempt or severe depression requiring hospitalization. 26. Presence of any other concomitant disease or laboratory result that may worsen under hormonal treatment based on Investigator's discretion. 27. Positive urine drug screen. 28. Recent history (within prior 12 months) of drug or alcohol abuse or at Investigator discretion, history greater than 12 months prior and at risk for noncompliance. Current or recent history of (recreational or medicinal) marijuana use is not exclusionary at the investigator's discretion upon assessment of any potential risk. 29. Participation in an investigational study within 30 days prior to enrollment or intention to participate within next 13 months.