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

Launched by MYLAN TECHNOLOGIES INC. · Nov 18, 2021

Keywords

ClinConnect Summary

MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg. This study will evaluate the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01.

Gender

FEMALE

Eligibility criteria

• 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 \<18 years are eligible provided that:
• • 1. Applicable national, state, and local laws allow the subject to consent to sexual intercourse,
• • 2. Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
• • 3. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
• • 2. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year.
• • 3. Has negative UPT results at screening and at enrollment visits.
• • 4. Has normal, regular menstrual cycles that are between 21 and 35 days.
• • 5. Engages in regular heterosexual vaginal intercourse.
• • 6. Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study.
• • 7. Able to understand and voluntarily provide written informed consent or assent to participate in the study.
• • 8. Able to understand and willing to be compliant with study procedures.
• • 9. Willing to accept a risk of pregnancy.
• • 10. Has demonstrated ability to complete e-Diary.
• • 11. Planning to reside within a reasonable driving/ public transport distance of the research 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 any components of the MR-100A-01 product.
• • 3. History or presence of dermal sensitivity to topical applications including bandages, surgical tape.
• • 4. Known infertility (current or known history) or history of sterilization in either partner.
• • 5. Received injectable hormonal contraceptive therapy within 10 months of study enrollment or has had less than 2 consecutive, spontaneous menses after an injectable hormonal contraceptive was received at least 10 months earlier.
• • 6. Current use of hormonal contraceptive implants (still implanted; or if an implant was removed, less than 3 consecutive spontaneous menses have occurred between removal and enrollment).
• • 7. Has non-hormonal or hormonal intrauterine device (IUD) in place or has had a recent IUD removal without one spontaneous menses after removal prior to the date of enrollment.
• • 8. Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal or cesarean delivery and have had less than 3 consecutive, spontaneous menses or withdrawal 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 for protection from sexually transmitted infections during the study or for emergency contraception.
• 11. Subjects having a known contraindication to combined hormonal contraception as listed below:
• • 1. Smoker who is ≥35 years old.
• • 2. History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs), valvular heart disease with complications (pulmonary hypertension, risk for atrial fibrillation, or history of subacute bacterial endocarditis), peripartum cardiomyopathy.
• • 3. History or presence of hypertension (including adequately controlled hypertension) or hypertension with vascular disease or elevated blood pressure (BP) defined as systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, measured in sitting position after 5 minutes of rest, considering the average of two readings measured 1 to 2 minutes apart
• • 4. History or presence of deep vein thrombosis/pulmonary embolism (DVT/PE) or superficial venous thrombosis.
• • 5. Has any comorbid condition that may require major surgery with prolonged immobilization during the study period.
• • 6. Subjects with known inherited or acquired hypercoagulopathy.
• • 7. History or presence of systemic lupus erythematosus.
• • 8. History or presence of neurological conditions including migraine with aura at any age, migraine without aura in women ≥35 years age or in women who smoke, or multiple sclerosis with prolonged immobility.
• • 9. History or presence of or suspected carcinoma of breast.
• • 10. Has diabetes mellitus with nephropathy, retinopathy, neuropathy, or other vascular disease or diabetes of \>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.