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

Completed · Phase 3

Conditions studied: Contraception

In brief

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

Key facts

Study ID

NCT05139121

Run by

Mylan Technologies Inc.

People needed

1319

Starts

2021-10-26

Expected to finish

2025-01-15

Last updated by the study team

2025-01-28

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 or has had less than 2 consecutive, spontaneous menses after an injectable hormonal contraceptive was received at least 10 months earlier.
• 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).
• 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.
• 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:
• Smoker who is ≥35 years old.
• 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.
• 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
• History or presence of deep vein thrombosis/pulmonary embolism (DVT/PE) or superficial venous thrombosis.
• 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 with aura at any age, migraine without aura in women ≥35 years age or in women who smoke, or multiple sclerosis with prolonged immobility.
• History or presence of or suspected carcinoma of breast.
• Has diabetes mellitus with nephropathy, retinopathy, neuropathy, or other vascular disease or diabetes of >20 years' duration.
• Has inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are at increased risk for VTE
• Medically treated or presence of symptomatic gall bladder disease.
• History of combined hormonal contraceptive/pregnancy-related cholestasis/jaundice.
• Presence of liver disease.

Where it is running

• Velocity Clinical Research — Mobile, Alabama, United States
• Mesa Obstetricians and Gynecologists. — Mesa, Arizona, United States
• Precision Trials AZ — Phoenix, Arizona, United States
• Visions Clinical Research Tucson — Tucson, Arizona, United States
• Alliance Research Institute — Bell Gardens, California, United States
• Essential Access Health — Berkeley, California, United States
• Velocity Clinical Research - Huntington Park — Huntington Park, California, United States
• Essential Access Health — Los Angeles, California, United States
• Axis Clinical Trials — Los Angeles, California, United States
• Matrix Clinical Research — Los Angeles, California, United States
• Velocity Clinical Research - Gardena — Los Angeles, California, United States
• Velocity Clinical Research, Panorama City — Los Angeles, California, United States
• Stanford University, School of Medicine, Department of Obstetrics and Gynecology — Palo Alto, California, United States
• Empire Clinical Research — Pomona, California, United States
• Northern California Research Corp — Sacramento, California, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• Wr-McCr, Llc — San Diego, California, United States
• Amicis Research Center — San Fernando, California, United States
• Red Rocks Ob-Gyn — Lakewood, Colorado, United States
• IntimMedicine Specialists — Washington D.C., District of Columbia, United States
• Quantum Clinical Trials — Boynton Beach, Florida, United States
• Aventura OB/GYN Associates — Hallandale, Florida, United States
• CenExel RCA — Hollywood, Florida, United States
• Global Research Associates — Homestead, Florida, United States
• Mobile Ob-Gyn, P.C. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.