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

NCT05139121 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: MR-100A-01-TD-3001
• Study Type: interventional
• Target: 1,319
• Locations: 3 countries
• Sites: 100

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

Conditions

Contraception

Keywords

Birth Control; Pregnancy Prevention; Contraceptive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Cycle-wise pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]

  12 months (13 cycles)

• Cumulative pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]

  12 months (13 cycles)

• Method failure Pearl Index (PI) [secondary efficacy]

  12 months (13 cycles)

• Incidence of adverse events (AEs) [safety and tolerability]

  12 months (13 cycles)

• Incidence of serious adverse events (SAEs) [safety and tolerability]

  12 months (13 cycles)

Study Arms (1)

MR-100A-01

EXPERIMENTAL

MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol

Drug: MR-100A-01

Interventions

MR-100A-01 DRUG

Transdermal contraceptive delivery system

Also known as: Transdermal contraceptive delivery system

MR-100A-01

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mylan Technologies Inc.: lead
• Mylan Inc.: collaborator

Study Sites (100)

Mobile Ob-Gyn, P.C.

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Mesa Obstetricians and Gynecologists.

Mesa, Arizona, 85206, United States

Location

Precision Trials AZ

Phoenix, Arizona, 85032, United States

Location

Visions Clinical Research Tucson

Tucson, Arizona, 85712, United States

Location

Alliance Research Institute

Bell Gardens, California, 90201, United States

Location

Essential Access Health

Berkeley, California, 94710, United States

Location

Velocity Clinical Research - Huntington Park

Huntington Park, California, 90255, United States

Location

Essential Access Health

Los Angeles, California, 90010, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Velocity Clinical Research - Gardena

Los Angeles, California, 90057, United States

Location

Velocity Clinical Research, Panorama City

Los Angeles, California, 90057, United States

Location

Stanford University, School of Medicine, Department of Obstetrics and Gynecology

Palo Alto, California, 94304, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Northern California Research Corp

Sacramento, California, 95821, United States

Location

Women's Health Care Research Corp.

San Diego, California, 92111, United States

Location

Wr-McCr, Llc

San Diego, California, 92120, United States

Location

Amicis Research Center

San Fernando, California, 91340, United States

Location

Red Rocks Ob-Gyn

Lakewood, Colorado, 80228, United States

Location

IntimMedicine Specialists

Washington D.C., District of Columbia, 20036, United States

Location

Quantum Clinical Trials

Boynton Beach, Florida, 33435, United States

Location

Aventura OB/GYN Associates

Hallandale, Florida, 33009, United States

Location

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Global Research Associates

Homestead, Florida, 33030, United States

Location

UF Health Woman's Specialist - Emerson

Jacksonville, Florida, 32207, United States

Location

Multi-Specialty Research Associates

Lake City, Florida, 32055, United States

Location

WR-Multi-Specialty Research Associates LLC

Lake City, Florida, 32055, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Ob-Gyn Associates Of Mid-Florida, PA

Leesburg, Florida, 34748, United States

Location

Advanced Pharma CR LLC

Miami, Florida, 33147, United States

Location

Avantis Clinical Research

Miami, Florida, 33155, United States

Location

AdMed Research, LLC

Miami, Florida, 33173, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

ProCare Research Center, Corp.

Miami Gardens, Florida, 33014, United States

Location

Global Health Research Center

Miami Lakes, Florida, 33016, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Healthcare Clinical Data, Inc. - Segal Institute for Clinica

North Miami, Florida, 33161, United States

Location

Clintheory Healthcare Miami

Orlando, Florida, 32819, United States

Location

Physician Care Clinical Research

Sarasota, Florida, 34239, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Agile Clinical Research Trials

Atlanta, Georgia, 30342, United States

Location

Medisense Inc.

Atlanta, Georgia, 30363, United States

Location

CenExel iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 30033-3500, United States

Location

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

Location

Fellows Research Alliance, Inc.

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States

Location

Clinical Trials Management

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research - Covington

Covington, Louisiana, 70433, United States

Location

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Velocity Clinical Research Metairie

Metairie, Louisiana, 70006, United States

Location

Javara Inc/Privia Medical Group, LLC

Chevy Chase, Maryland, 20815, United States

Location

SBL Special Services

Frederick, Maryland, 21702, United States

Location

Planned Parenthood of Minnesota

Minneapolis, Minnesota, 55408, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Office of Edmond Pack, MD

Las Vegas, Nevada, 89113, United States

Location

Wake Research Clinical Research Center of Nevada - Emergency Medicine

Las Vegas, Nevada, 89123, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Velocity Clinical Research- Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Bosque Women's Care

Albuquerque, New Mexico, 87109, United States

Location

New York Clinical Trials - Brooklyn

Brooklyn, New York, 11201, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Upstate Clinical Research Associates

Williamsville, New York, 14221, United States

Location

Javara Inc. Tryon Medical-South Park

Charlotte, North Carolina, 28210, United States

Location

Carolina Women's Research And Wellness Center

Durham, North Carolina, 27713, United States

Location

Unified Women's Clinical Research Raleigh

Raleigh, North Carolina, 27607, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Unified Women's Clinical Research d/b/a Lyndhurst Clinical R

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-1716, United States

Location

Velocity Clinical Research, Cleveland

Cleveland, Ohio, 44122, United States

Location

Aventiv Research - Columbus

Dublin, Ohio, 43016, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Health & Science University Center for Women's Health

Portland, Oregon, 97201, United States

Location

Ob/Gyn Associates Of Erie

Erie, Pennsylvania, 16507, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Velocity Clinical Research-Charleston

Charleston, South Carolina, 29414, United States

Location

Venus Gynecology, LLC.

Myrtle Beach, South Carolina, 29572-4177, United States

Location

Chattanooga Medical Research LLC

Chattanooga, Tennessee, 37404, United States

Location

Alliance for Multispecialty Research, LLC.

Knoxville, Tennessee, 37920, United States

Location

WR-Medical Research Center of Memphis, LLC.

Memphis, Tennessee, 38120, United States

Location

DCT-HCWC, LLC dba Discovery Clinical Trials

Dallas, Texas, 75230, United States

Location

Cedar Health Research

Irving, Texas, 75251, United States

Location

Advances In Health, Inc.

Pearland, Texas, 77584, United States

Location

Physicians' Research Options, LLC Corner Canyon Clinic

Draper, Utah, 84020, United States

Location

Physicians' Research Options, LLC

Pleasant Grove, Utah, 84062, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, 84088, United States

Location

Tidewater Clinical Research/TPW

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical School, Clinical Research Center

Norfolk, Virginia, 23507, United States

Location

Virginia Women's Health Associates

Reston, Virginia, 20192, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

Centricity Research Quebec City

Lévis, Quebec, G6W 0M5, Canada

Location

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 6P6, Canada

Location

Clinique RSF Inc.

Québec, G1V 3M7, Canada

Location

Puerto Rico Medical Research, Inc

Ponce, 717, Puerto Rico

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: December 1, 2021
• Study Start: October 26, 2021
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (96); CA (3)