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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception
• Intervention / Treatment: Drug: MR-100A-01

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.

• Study Type: Interventional
• Enrollment (Actual): 1321
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Prasanna C Ganapathi; Phone Number: +91 80 6672 8952; Email: PrasannaC.Ganapathi@viatris.com

Study Locations

• Canada
  • Quebec, Canada, G1V 3M7
    • Clinique RSF Inc.
  • Quebec
    • Levis, Quebec, Canada, G6W 0M5
      • Centricity Research Quebec City
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriaville
• Puerto Rico
  • Ponce, Puerto Rico, 717
    • Puerto Rico Medical Research, Inc
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Mobile Ob-Gyn, P.C.
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Mesa Obstetricians and Gynecologists.
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research Tucson
  • California
    • Bell Gardens, California, United States, 90201
      • Alliance Research Institute
    • Berkeley, California, United States, 94710
      • Essential Access Health
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research - Huntington Park
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research
    • Los Angeles, California, United States, 90010
      • Essential Access Health
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research - Gardena
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research, Panorama City
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine, Department of Obstetrics and Gynecology
    • Pomona, California, United States, 91767
      • Empire Clinical Research
    • Sacramento, California, United States, 95821
      • Northern California Research Corp
    • San Diego, California, United States, 92111
      • Women's Health Care Research Corp.
    • San Diego, California, United States, 92120
      • Wr-McCr, Llc
    • San Fernando, California, United States, 91340
      • Amicis Research Center
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Red Rocks Ob-Gyn
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • IntimMedicine Specialists
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Quantum Clinical Trials
    • Hallandale Beach, Florida, United States, 33009
      • Aventura OB/GYN Associates
    • Hollywood, Florida, United States, 33024
      • CenExel RCA
    • Homestead, Florida, United States, 33030
      • Global Research Associates
    • Jacksonville, Florida, United States, 32207
      • UF Health Woman's Specialist - Emerson
    • Lake City, Florida, United States, 32055
      • Multi-Specialty Research Associates
    • Lake City, Florida, United States, 32055
      • WR-Multi-Specialty Research Associates LLC
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Leesburg, Florida, United States, 34748
      • OB-GYN Associates of Mid-Florida, PA
    • Miami, Florida, United States, 33155
      • Avantis Clinical Research
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR LLC
    • Miami, Florida, United States, 33173
      • Admed Research, LLC
    • Miami Gardens, Florida, United States, 33014
      • ProCare Research Center, Corp.
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research Center
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data, Inc. - Segal Institute for Clinica
    • Orlando, Florida, United States, 32819
      • Clintheory Healthcare Miami
    • Sarasota, Florida, United States, 34239
      • Physician Care Clinical Research
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials, Llc
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Agile Clinical Research Trials
    • Atlanta, Georgia, United States, 30363
      • Medisense Inc.
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch Atlanta, LLC
    • Decatur, Georgia, United States, 30033-3500
      • Soapstone Center for Clinical Research
    • Sandy Springs, Georgia, United States, 30328
      • WR-Mount Vernon Clinical Research, LLC
    • Savannah, Georgia, United States, 31406
      • Fellows Research Alliance, Inc.
    • Savannah, Georgia, United States, 31405
      • CenExel iResearch, LLC
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research, Boise
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management
    • Covington, Louisiana, United States, 70433
      • Velocity Clinical Research - Covington
    • Marrero, Louisiana, United States, 70072
      • Praetorian Pharmaceutical Research, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Javara Inc/Privia Medical Group, LLC
    • Frederick, Maryland, United States, 21702
      • SBL Special Services
  • Minnesota
    • Minneapolis, Minnesota, United States, 55408
      • Planned Parenthood of Minnesota
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
    • Las Vegas, Nevada, United States, 89113
      • Office of Edmond Pack, MD
    • Las Vegas, Nevada, United States, 89123
      • Wake Research Clinical Research Center of Nevada - Emergency Medicine
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clinical Research- Albuquerque
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Williamsville, New York, United States, 14221
      • Upstate Clinical Research Associates
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Javara Inc. Tryon Medical-South Park
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research and Wellness Center
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
    • Raleigh, North Carolina, United States, 27607
      • Unified Women's Clinical Research Raleigh
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research d/b/a Lyndhurst Clinical R
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research, Cleveland
    • Cleveland, Ohio, United States, 44106-1716
      • University Hospitals Cleveland Medical Center
    • Dublin, Ohio, United States, 43016
      • Aventiv Research - Columbus
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University Center for Women's Health
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • OB/GYN Associates of Erie
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Medical Center
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15213-3180
      • University of Pittsburgh Medical Center (UPMC)
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Velocity Clinical Research-Charleston
    • Myrtle Beach, South Carolina, United States, 29572-4177
      • Venus Gynecology, LLC.
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research LLC
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC.
    • Memphis, Tennessee, United States, 38120
      • WR-Medical Research Center of Memphis, LLC.
  • Texas
    • Dallas, Texas, United States, 75230
      • DCT-HCWC, LLC dba Discovery Clinical Trials
    • Irving, Texas, United States, 75251
      • Cedar Health Research
    • Pearland, Texas, United States, 77584
      • Advances in Health, Inc.
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians' Research Options, LLC Corner Canyon Clinic
    • Pleasant Grove, Utah, United States, 84062
      • Physicians' Research Options, LLC
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research - Salt Lake City
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research/TPW
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School, Clinical Research Center
    • Reston, Virginia, United States, 20192
      • Virginia Women's Health Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MR-100A-01; MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol	Drug: MR-100A-01; Transdermal contraceptive delivery system; Other Names: Transdermal contraceptive delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years times 100	12 months (13 cycles)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycle-wise pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]	The rate of cycle-wise pregnancies	12 months (13 cycles)
Cumulative pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]	The rate of cycle-wise pregnancies	12 months (13 cycles)
Method failure Pearl Index (PI) [secondary efficacy]	The method failure PI is defined as PI among all complete or incomplete on therapy cycles in which intercourse occurred and protocol guidelines were not followed	12 months (13 cycles)
Incidence of adverse events (AEs) [safety and tolerability]	The number of AEs	12 months (13 cycles)
Incidence of serious adverse events (SAEs) [safety and tolerability]	The number of SAEs	12 months (13 cycles)
Incidence of application site reactions [safety and tolerability]	The number of application site reactions	12 months (13 cycles)
Number of episodes of scheduled and unscheduled bleeding [cycle control]	The number of incidences of scheduled and unscheduled bleeding	12 months (13 cycles)
Number of days of scheduled and unscheduled bleeding [cycle control]	The observed number of days of scheduled or unscheduled bleeding	12 months (13 cycles)
Proportion of subjects reporting scheduled and unscheduled bleeding [cycle control]	The number of subjects reporting scheduled and unscheduled bleeding	12 months (13 cycles)
Adhesion performance as measured by adhesion scores [patch adhesion]	The descriptive figures of adhesion performance	12 months (13 cycles)

Collaborators and Investigators

• Sponsor: Mylan Technologies Inc.
• Collaborators: Mylan Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Contraceptive; Birth Control; Pregnancy Prevention
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: MR-100A-01-TD-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No