Patch tested to block pregnancy

NCT ID NCT05139121

Prevention Sponsor: Mylan Technologies Inc. Source: ClinicalTrials.gov ↗

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a transdermal contraceptive patch called MR-100A-01 to see how well it prevents pregnancy in women of childbearing potential. The study enrolls about 1,320 healthy women aged 16 and older who are at risk of pregnancy. Participants use the patch for up to 13 menstrual cycles, and researchers track pregnancy rates, cycle control, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: a transdermal contraceptive patch
What this could lead to: If it works, this could offer women a new patch option for preventing pregnancy.
What could go wrong: The patch may not prevent pregnancy as well as existing methods, and some women may have skin reactions or other side effects. The study is open-label, so everyone knows they are using the patch, which can affect how results are interpreted.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,320 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

Contacts and locations

Locations

AdMed Research, LLC

Miami, Florida, 33173, United States
Advanced Pharma CR LLC

Miami, Florida, 33147, United States
Advances In Health, Inc.

Pearland, Texas, 77584, United States
Agile Clinical Research Trials

Atlanta, Georgia, 30342, United States
Alliance Research Institute

Bell Gardens, California, 90201, United States
Alliance for Multispecialty Research, LLC.

Knoxville, Tennessee, 37920, United States
Altus Research

Lake Worth, Florida, 33461, United States
Amicis Research Center

San Fernando, California, 91340, United States
Avantis Clinical Research

Miami, Florida, 33155, United States
Aventiv Research - Columbus

Dublin, Ohio, 43016, United States
Aventura OB/GYN Associates

Hallandale, Florida, 33009, United States
Axis Clinical Trials

Los Angeles, California, 90036, United States
Bosque Women's Care

Albuquerque, New Mexico, 87109, United States
Carolina Women's Research And Wellness Center

Durham, North Carolina, 27713, United States
Cedar Health Research

Irving, Texas, 75251, United States
CenExel RCA

Hollywood, Florida, 33024, United States
CenExel iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States
CenExel iResearch, LLC

Savannah, Georgia, 31405, United States
Centricity Research Quebec City

Lévis, Quebec, G6W 0M5, Canada
Chattanooga Medical Research LLC

Chattanooga, Tennessee, 37404, United States
Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States
Clinical Trials Management

Covington, Louisiana, 70433, United States
Clinique RSF Inc.

Québec, Quebec, G1V 3M7, Canada
Clintheory Healthcare Miami

Orlando, Florida, 32819, United States
Columbia University Medical Center

New York, New York, 10032, United States
Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States
DCT-HCWC, LLC dba Discovery Clinical Trials

Dallas, Texas, 75230, United States
Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 6P6, Canada
Eastern Virginia Medical School, Clinical Research Center

Norfolk, Virginia, 23507, United States
Empire Clinical Research

Pomona, California, 91767, United States
Essential Access Health

Berkeley, California, 94710, United States
Essential Access Health

Los Angeles, California, 90010, United States
Excel Clinical Research

Las Vegas, Nevada, 89109, United States
Fellows Research Alliance, Inc.

Savannah, Georgia, 31406, United States
Global Health Research Center

Miami Lakes, Florida, 33016, United States
Global Research Associates

Homestead, Florida, 33030, United States
Hassman Research Institute

Marlton, New Jersey, 08053, United States
Healthcare Clinical Data, Inc. - Segal Institute for Clinica

North Miami, Florida, 33161, United States
IntimMedicine Specialists

Washington D.C., District of Columbia, 20036, United States
Javara Inc. Tryon Medical-South Park

Charlotte, North Carolina, 28210, United States
Javara Inc/Privia Medical Group, LLC

Chevy Chase, Maryland, 20815, United States
Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States
M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States
Matrix Clinical Research

Los Angeles, California, 90057, United States
Medisense Inc.

Atlanta, Georgia, 30363, United States
Mesa Obstetricians and Gynecologists.

Mesa, Arizona, 85206, United States
Mobile Ob-Gyn, P.C.

Mobile, Alabama, 36608, United States
Montefiore Medical Center

The Bronx, New York, 10461, United States
Multi-Specialty Research Associates

Lake City, Florida, 32055, United States
New Age Medical Research Corporation

Miami, Florida, 33186, United States
New York Clinical Trials - Brooklyn

Brooklyn, New York, 11201, United States
Northern California Research Corp

Sacramento, California, 95821, United States
Ob-Gyn Associates Of Mid-Florida, PA

Leesburg, Florida, 34748, United States
Ob/Gyn Associates Of Erie

Erie, Pennsylvania, 16507, United States
Office of Edmond Pack, MD

Las Vegas, Nevada, 89113, United States
Oregon Health & Science University Center for Women's Health

Portland, Oregon, 97201, United States
Physician Care Clinical Research

Sarasota, Florida, 34239, United States
Physicians' Research Options, LLC

Pleasant Grove, Utah, 84062, United States
Physicians' Research Options, LLC Corner Canyon Clinic

Draper, Utah, 84020, United States
Planned Parenthood of Minnesota

Minneapolis, Minnesota, 55408, United States
Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, 70072, United States
Precision Trials AZ

Phoenix, Arizona, 85032, United States
ProCare Research Center, Corp.

Miami Gardens, Florida, 33014, United States
Puerto Rico Medical Research, Inc

Ponce, 717, Puerto Rico
Quantum Clinical Trials

Boynton Beach, Florida, 33435, United States
Red Rocks Ob-Gyn

Lakewood, Colorado, 80228, United States
SBL Special Services

Frederick, Maryland, 21702, United States
Seattle Clinical Research Center

Seattle, Washington, 98105, United States
Soapstone Center for Clinical Research

Decatur, Georgia, 30033-3500, United States
Stanford University, School of Medicine, Department of Obstetrics and Gynecology

Palo Alto, California, 94304, United States
Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States
Tidewater Clinical Research/TPW

Norfolk, Virginia, 23502, United States
UF Health Woman's Specialist - Emerson

Jacksonville, Florida, 32207, United States
Unified Women's Clinical Research Raleigh

Raleigh, North Carolina, 27607, United States
Unified Women's Clinical Research d/b/a Lyndhurst Clinical R

Winston-Salem, North Carolina, 27103, United States
University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-1716, United States
University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213-3180, United States
Upstate Clinical Research Associates

Williamsville, New York, 14221, United States
Velocity Clinical Research

Mobile, Alabama, 36608, United States
Velocity Clinical Research - Covington

Covington, Louisiana, 70433, United States
Velocity Clinical Research - Gardena

Los Angeles, California, 90057, United States
Velocity Clinical Research - Huntington Park

Huntington Park, California, 90255, United States
Velocity Clinical Research - Salt Lake City

West Jordan, Utah, 84088, United States
Velocity Clinical Research Metairie

Metairie, Louisiana, 70006, United States
Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States
Velocity Clinical Research, Cleveland

Cleveland, Ohio, 44122, United States
Velocity Clinical Research, Panorama City

Los Angeles, California, 90057, United States
Velocity Clinical Research- Albuquerque

Albuquerque, New Mexico, 87107, United States
Velocity Clinical Research-Charleston

Charelston, South Carolina, 29414, United States
Venus Gynecology, LLC.

Myrtle Beach, South Carolina, 29572-4177, United States
Virginia Women's Health Associates

Reston, Virginia, 20192, United States
Visions Clinical Research Tucson

Tucson, Arizona, 85712, United States
WR-Medical Research Center of Memphis, LLC.

Memphis, Tennessee, 38120, United States
WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States
WR-Multi-Specialty Research Associates LLC

Lake City, Florida, 32055, United States
Wake Research Clinical Research Center of Nevada - Emergency Medicine

Las Vegas, Nevada, 89123, United States
Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States
Women's Health Care Research Corp.

San Diego, California, 92111, United States
Wr-McCr, Llc

San Diego, California, 92120, United States

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