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

  • STATUS
    Recruiting
  • End date
    Sep 29, 2023
  • participants needed
    1200
  • sponsor
    Mylan Technologies Inc.
Updated on 29 July 2022
Investigator
Prasanna C Ganapathi
Primary Contact
Mylan Investigator Site (7.9 mi away) Contact
+44 other location
hormonal contraception
regular menstrual cycles
Accepts healthy volunteers

Summary

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

Description

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.

Details
Condition Contraception
Treatment MR-100A-01
Clinical Study IdentifierNCT05139121
SponsorMylan Technologies Inc.
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Applicable national, state, and local laws allow the subject to consent to sexual intercourse
Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed
Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1
year
Has negative UPT results at screening and at enrollment visits
Has normal, regular menstrual cycles that are between 21 and 35 days
Engages in regular heterosexual vaginal intercourse
Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study
Able to understand and voluntarily provide written informed consent or assent to participate in the study
Able to understand and willing to be compliant with study procedures
Willing to accept a risk of pregnancy
Has demonstrated ability to complete e-Diary
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

Known or suspected pregnancy or planning pregnancy during next 12 months
Subjects with known hypersensitivity or intolerance to estrogens, progestins, or any components of the MR-100A-01 product
History or presence of dermal sensitivity to topical applications including bandages, surgical tape
Known infertility (current or known history) or history of sterilization in either partner
Received injectable hormonal contraceptive therapy within 10 months of study enrollment
Use of hormonal contraceptive implants (still implanted or only less than 3 consecutive spontaneous menses have occurred since removal at enrollment)
Has hormonal/non-hormonal intrauterine device (IUD) in place without one spontaneous menses after removal or had progestin releasing IUD in place within 3 months of study enrollment
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
Subjects lactating at the time of screening into the study
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
Subjects having a known contraindication to combined hormonal contraception as listed
below
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
Smoker who is ≥35 years old
History or presence of deep vein thrombosis/pulmonary embolism or superficial venous thrombosis
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
Has any comorbid condition that may require major surgery with prolonged immobilization during the study period
Subjects with known inherited or acquired hypercoagulopathy
History or presence of systemic lupus erythematosus
History or presence of neurological conditions including migraine or multiple sclerosis with prolonged immobility
History or presence of or suspected carcinoma of breast
Has diabetes mellitus with vascular disease
Has inflammatory bowel disease
Medically treated or presence of symptomatic gall bladder disease
History of combined hormonal contraceptive/pregnancy related cholestasis/jaundice
Presence of liver disease
History of organ transplantation within 5 years before screening
Subject has requirement to be on treatment with medications prohibited during study
History of any other condition that in the Investigator's opinion suggests an elevated risk of arterial or venous thromboembolic disease
Known or suspected estrogen or progestin sensitive malignant or premalignant
conditions
Has uncontrolled thyroid disorder
Has diagnosis of hereditary angioedema
Has hyperlipidemia on screening
Has uncontrolled diabetes mellitus
Subjects with abnormal significant liver function tests
Has a significantly abnormal cervical cancer screening test at screening visit
Subjects with chlamydial or gonorrheal infection
Has unexplained vaginal bleeding
History of known or suspected hepatitis B or C infection or high risk for sexually transmitted disease (STD)
Known human immunodeficiency virus (HIV) infection or positive test at screening
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 vaccination
History of suicidal ideation or attempt, or history of severe depression requiring hospitalization within the past year
Presence of any other concomitant disease or laboratory result that may worsen under hormonal treatment based on Investigator's discretion
Positive urine drug screen
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
Participation in an investigational study within 30 days prior to enrollment or intention to participate within next 13 months
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