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

Inclusion Criteria:

1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are atleast 16 years of age with no upper age limit. Post-menarcheal female subjects whoare at risk of pregnancy, and <18 years are eligible provided that:

2. Applicable national, state, and local laws allow the subject to consent tosexual intercourse,

3. Applicable national, state, and local laws allow subjects in this age group toconsent/assent to receive contraceptive services, and

4. All applicable laws and regulations regarding the informed consent/assent ofthe subjects to participate in clinical trials are observed.

5. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1year.

6. Has negative UPT results at screening and at enrollment visits.

7. Has normal, regular menstrual cycles that are between 21 and 35 days.

8. Engages in regular heterosexual vaginal intercourse.

9. Agrees not to use other contraceptives or other methodology to prevent pregnancyduring the study.

10. Able to understand and voluntarily provide written informed consent or assent toparticipate in the study.

11. Able to understand and willing to be compliant with study procedures.

12. Willing to accept a risk of pregnancy.

13. Has demonstrated ability to complete e-Diary.

14. Planning to reside within a reasonable driving/ public transport distance of theresearch site (approximately 150 miles) for around 12 months (13 cycles).

Exclusion Criteria:

1. Known or suspected pregnancy or planning pregnancy during next 12 months.

2. Subjects with known hypersensitivity or intolerance to estrogens, progestins, or anycomponents of the MR-100A-01 product.

3. History or presence of dermal sensitivity to topical applications includingbandages, surgical tape.

4. Known infertility (current or known history) or history of sterilization in eitherpartner.

5. Received injectable hormonal contraceptive therapy within 10 months of studyenrollment or has had less than 2 consecutive, spontaneous menses after aninjectable hormonal contraceptive was received at least 10 months earlier.

6. Current use of hormonal contraceptive implants (still implanted; or if an implantwas removed, less than 3 consecutive spontaneous menses have occurred betweenremoval and enrollment).

7. Has non-hormonal or hormonal intrauterine device (IUD) in place or has had a recentIUD removal without one spontaneous menses after removal prior to the date ofenrollment.

8. Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal orcesarean delivery and have had less than 3 consecutive, spontaneous menses orwithdrawal bleeding episodes prior to enrollment.

9. Subjects lactating at the time of screening into the study.

10. Anticipates routine use of condoms or any other form of back-up contraception forprotection from sexually transmitted infections during the study or for emergencycontraception.

11. Subjects having a known contraindication to combined hormonal contraception aslisted below:

12. Smoker who is ≥35 years old.

13. History or presence of ischemic heart disease, coronary artery disease,myocardial infarction, stroke, other cerebrovascular diseases includingtransient ischemic attacks (TIAs), valvular heart disease with complications (pulmonary hypertension, risk for atrial fibrillation, or history of subacutebacterial endocarditis), peripartum cardiomyopathy.

14. History or presence of hypertension (including adequately controlledhypertension) or hypertension with vascular disease or elevated blood pressure (BP) defined as systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, measured insitting position after 5 minutes of rest, considering the average of tworeadings measured 1 to 2 minutes apart

15. History or presence of deep vein thrombosis/pulmonary embolism (DVT/PE) orsuperficial venous thrombosis.

16. Has any comorbid condition that may require major surgery with prolongedimmobilization during the study period.

17. Subjects with known inherited or acquired hypercoagulopathy.

18. History or presence of systemic lupus erythematosus.

19. History or presence of neurological conditions including migraine with aura atany age, migraine without aura in women ≥35 years age or in women who smoke, ormultiple sclerosis with prolonged immobility.

20. History or presence of or suspected carcinoma of breast.

21. Has diabetes mellitus with nephropathy, retinopathy, neuropathy, or othervascular disease or diabetes of >20 years' duration.

22. Has inflammatory bowel disease (ulcerative colitis or Crohn's disease) who areat increased risk for VTE

23. Medically treated or presence of symptomatic gall bladder disease.

24. History of combined hormonal contraceptive/pregnancy-relatedcholestasis/jaundice.

25. Presence of liver disease.

26. History of organ transplantation within 5 years before screening or chronicdisease potentially necessitating organ transplantation during the anticipatedcourse of the study.

27. Subject has requirement to be on treatment with medications prohibited duringstudy.

28. Known or suspected estrogen or progestin sensitive malignant or premalignantconditions.

29. History of any other condition that in the Investigator's opinion suggests anelevated risk of arterial or venous thromboembolic disease.

30. Has uncontrolled thyroid disorder.

31. Has diagnosis of hereditary angioedema.

32. Has hyperlipidemia on screening.

33. Has uncontrolled diabetes mellitus.

34. Subjects with abnormal significant liver function tests.

35. Has a significantly abnormal cervical cancer screening test (cervical cytology withreflex human-papilloma-virus (HPV) testing or with HPV co-testing) performed atscreening visit (for subjects aged ≥21 years) i.e., cervical dysplasia or invasivecervical cancer or has any abnormal cytology with/without HPV testing during 6months prior to screening which may require additional screening or treatment duringthe study period

36. Subjects with chlamydial or gonorrheal infection.

37. Has unexplained vaginal bleeding.

38. History of known or suspected hepatitis B or C infection or high risk for sexuallytransmitted disease (STD).

39. Known human immunodeficiency virus (HIV) infection or positive confirmatory test atscreening.

40. Current known active infection of coronavirus disease 2019 (COVID-19) or increasedrisk of COVID-19 related morbidity. Subjects who have had previous COVID-19infections but have recovered by the time of enrollment visit may be enrolled ifthere are no current COVID-19 symptoms; Subjects who had previously receivedCOVID-19 vaccine may be enrolled irrespective of the timing of the vaccination.

41. Within the past year, either history of suicidal ideation or attempt or severedepression requiring hospitalization.

42. Presence of any other concomitant disease or laboratory result that may worsen underhormonal treatment based on Investigator's discretion.

43. Positive urine drug screen.

44. Recent history (within prior 12 months) of drug or alcohol abuse or at Investigatordiscretion, history greater than 12 months prior and at risk for noncompliance.Current or recent history of (recreational or medicinal) marijuana use is notexclusionary at the investigator's discretion upon assessment of any potential risk.

45. Participation in an investigational study within 30 days prior to enrollment orintention to participate within next 13 months.