Clinical trial NCT05139121: Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
Official title: A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Birth Control
Pregnancy Prevention
Contraceptive
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan Inc.
First posted: 2021-12-01
Enrollment: 1319
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

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.

Primary outcomes:
measure: Contraceptive efficacy of MR-100A-01 when used over thirteen 28-day cycles in healthy, post-menarcheal, premenopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age and at risk of pregnancy
timeFrame: 12 months (13 cycles)
Secondary outcomes:
measure: Cycle-wise pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]
timeFrame: 12 months (13 cycles)
measure: Cumulative pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]
timeFrame: 12 months (13 cycles)
measure: Method failure Pearl Index (PI) [secondary efficacy]
timeFrame: 12 months (13 cycles)
measure: Incidence of adverse events (AEs) [safety and tolerability]
timeFrame: 12 months (13 cycles)
measure: Incidence of serious adverse events (SAEs) [safety and tolerability]
timeFrame: 12 months (13 cycles)
measure: Incidence of application site reactions [safety and tolerability]
timeFrame: 12 months (13 cycles)
measure: Number of episodes of scheduled and unscheduled bleeding [cycle control]
timeFrame: 12 months (13 cycles)
measure: Number of days of scheduled and unscheduled bleeding [cycle control]
timeFrame: 12 months (13 cycles)
measure: Proportion of subjects reporting scheduled and unscheduled bleeding [cycle control]
timeFrame: 12 months (13 cycles)
measure: Adhesion performance as measured by adhesion scores [patch adhesion]
timeFrame: 12 months (13 cycles)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Ob-Gyn, P.C.
state: Alabama
city: Mobile
country: United States
facility: Velocity Clinical Research
state: Alabama
city: Mesa
country: United States
facility: Mesa Obstetricians and Gynecologists.
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials AZ
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research Tucson
state: Arizona
city: Bell Gardens
country: United States
facility: Alliance Research Institute
state: California
city: Berkeley
country: United States
facility: Essential Access Health
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research - Huntington Park
state: California
city: Los Angeles
country: United States
facility: Essential Access Health
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Gardena
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Panorama City
state: California
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine, Department of Obstetrics and Gynecology
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: San Diego
country: United States
facility: Women's Health Care Research Corp.
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: San Fernando
country: United States
facility: Amicis Research Center
state: California
city: Lakewood
country: United States
facility: Red Rocks Ob-Gyn
state: Colorado
city: Washington
country: United States
facility: IntimMedicine Specialists
state: District of Columbia
city: Boynton Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Hallandale Beach
country: United States
facility: Aventura OB/GYN Associates
state: Florida
city: Hollywood
country: United States
facility: CenExel RCA
state: Florida
city: Homestead
country: United States
facility: Global Research Associates
state: Florida
city: Jacksonville
country: United States
facility: UF Health Woman's Specialist - Emerson
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates
state: Florida
city: Lake City
country: United States
facility: WR-Multi-Specialty Research Associates LLC
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Leesburg
country: United States
facility: Ob-Gyn Associates Of Mid-Florida, PA
state: Florida
city: Miami Gardens
country: United States
facility: ProCare Research Center, Corp.
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR LLC
state: Florida
city: Miami
country: United States
facility: Avantis Clinical Research
state: Florida
city: Miami
country: United States
facility: AdMed Research, LLC
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc. - Segal Institute for Clinica
state: Florida
city: Orlando
country: United States
facility: Clintheory Healthcare Miami
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials
state: Georgia
city: Atlanta
country: United States
facility: Medisense Inc.
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch Atlanta, LLC
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Savannah
country: United States
facility: Fellows Research Alliance, Inc.
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Covington
country: United States
facility: Clinical Trials Management
state: Louisiana
city: Covington
country: United States
facility: Velocity Clinical Research - Covington
state: Louisiana
city: Marrero
country: United States
facility: Praetorian Pharmaceutical Research, LLC
state: Louisiana
city: Metairie
country: United States
facility: Velocity Clinical Research Metairie
state: Louisiana
city: Chevy Chase
country: United States
facility: Javara Inc/Privia Medical Group, LLC
state: Maryland
city: Frederick
country: United States
facility: SBL Special Services
state: Maryland
city: Minneapolis
country: United States
facility: Planned Parenthood of Minnesota
state: Minnesota
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Office of Edmond Pack, MD
state: Nevada
city: Las Vegas
country: United States
facility: Wake Research Clinical Research Center of Nevada - Emergency Medicine
state: Nevada
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Albuquerque
country: United States
facility: Velocity Clinical Research- Albuquerque
state: New Mexico
city: Albuquerque
country: United States
facility: Bosque Women's Care
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Clinical Trials - Brooklyn
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Charlotte
country: United States
facility: Javara Inc. Tryon Medical-South Park
state: North Carolina
city: Durham
country: United States
facility: Carolina Women's Research And Wellness Center
state: North Carolina
city: Raleigh
country: United States
facility: Unified Women's Clinical Research Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research d/b/a Lyndhurst Clinical R
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research - Columbus
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University Center for Women's Health
state: Oregon
city: Erie
country: United States
facility: Ob/Gyn Associates Of Erie
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Charleston
country: United States
facility: Velocity Clinical Research-Charleston
state: South Carolina
city: Myrtle Beach
country: United States
facility: Venus Gynecology, LLC.
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Medical Research LLC
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC.
state: Tennessee
city: Memphis
country: United States
facility: WR-Medical Research Center of Memphis, LLC.
state: Tennessee
city: Dallas
country: United States
facility: DCT-HCWC, LLC dba Discovery Clinical Trials
state: Texas
city: Irving
country: United States
facility: Cedar Health Research
state: Texas
city: Pearland
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Draper
country: United States
facility: Physicians' Research Options, LLC Corner Canyon Clinic
state: Utah
city: Pleasant Grove
country: United States
facility: Physicians' Research Options, LLC
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research - Salt Lake City
state: Utah
city: Norfolk
country: United States
facility: Tidewater Clinical Research/TPW
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School, Clinical Research Center
state: Virginia
city: Reston
country: United States
facility: Virginia Women's Health Associates
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Levis
country: Canada
facility: Centricity Research Quebec City
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriaville
state: Quebec
city: Quebec
country: Canada
facility: Clinique RSF Inc.
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research, Inc
Study officials:
References: