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New birth control patch could offer hormonal option without estrogen

NCT ID NCT06672016

Disease control Sponsor: Mylan Pharmaceuticals Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study is testing a new contraceptive patch (MR-130A-01) that delivers a progestin-only hormone through the skin. About 1630 healthy women of childbearing potential will use the patch for 13 cycles to see how well it prevents pregnancy and how safe it is. The study is open-label and single-arm, meaning all participants receive the patch.

What this could mean

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

Active substance
progestin-only contraceptive patch (MR-130A-01)
What this could lead to
If successful, this could provide a new, easy-to-use contraceptive option for women, especially those who cannot take estrogen.
What could go wrong
This is a single-arm study without a comparison group, so results may be less definitive. The patch may cause skin irritation or have lower effectiveness in some women.

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

About 1,630 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

May 2027

An estimate. End dates often move.

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. 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 in duration over the last 6 months. 5. Engages in regular heterosexual vaginal intercourse (at least once per cycle), with a partner who is not known to be sub fertile or infertile. 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 (if the participant is adolescent prior to undergoing any trial related procedure) to participate in the study. Exclusion Criteria: 1. Known or suspected pregnancy or planning pregnancy during next 12 months. 2. Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch. 3. History or presence of dermal sensitivity to medicated patches or 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. 6. Current use of hormonal contraceptive implants. 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. 9. Participants lactating at the time of screening into the study or has occurrence of less than 3 regular menstrual cycles after cessation of lactation. 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. Participants having a known contraindication to progestin-only contraception. 12. Known or suspected progestin sensitive malignant or premalignant conditions including but not limited to carcinoma of endometrium, ovary, or fallopian tubes. 13. Skin abnormality (e.g., tattoo or scar) at all possible application sites. 14. Long-term treatment with drugs or herbal products that are moderate/strong inducers or inhibitors of CYP3A4. 15. Has uncontrolled thyroid disorder (thyrotoxicosis or myxedema). 16. Has diagnosis of hereditary angioedema. 17. Participants with abnormal significant liver function tests as measured by liver function tests 18. Has a significantly abnormal cervical cancer screening test. 19. Participants with chlamydial or gonorrheal infection at screening. 20. Has unexplained vaginal bleeding within the past 6 months or any abnormal bleeding which is expected to recur during the study.

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As listed by the trial registrant

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

Female contraception

Contacts and locations

Locations

  • ACRC Trials

    Frisco, Texas, 75033, United States

  • AMR Lexington

    Lexington, Kentucky, 40509, United States

  • AMR Mobile

    Mobile, Alabama, 36608, United States

  • AMR Newton

    Newton, Kansas, 67114, United States

  • AMR Norfolk

    Norfolk, Virginia, 23502, United States

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235, United States

  • Albuquerque Clinic Trials Inc

    Albuquerque, New Mexico, 87102, United States

  • Alliance for Multispecialty Research

    Kansas City, Missouri, 64114, United States

  • Altus Research

    Lake Worth, Florida, 33461, United States

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109, United States

  • Cedar Health Research, LLC

    Euless, Texas, 76040, United States

  • CenExel Hassman Research Institute

    Marlton, New Jersey, 08053, United States

  • CenExel Savannah

    Savannah, Georgia, 31405, United States

  • CenExel iResearch LLC

    Decatur, Georgia, 30030, United States

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060, United States

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Trial Network LLC

    Houston, Texas, 77074, United States

  • Clinical Trials Management, LLC

    Covington, Louisiana, 70433, United States

  • Essential Access Health

    Los Angeles, California, 90017, United States

  • Essential Women's Health

    Las Vegas, Nevada, 89113, United States

  • Excel Clinical Research

    Las Vegas, Nevada, 89109, United States

  • Genoma Research Group

    Miami, Florida, 33173, United States

  • Helios Clinical Research

    Fort Worth, Texas, 76104, United States

  • Helios Clinical Research

    Weatherford, Texas, 76086, United States

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157, United States

  • Javara

    Houston, Texas, 77054, United States

  • Javara

    Rowlett, Texas, 75088, United States

  • Javara

    Sugarland, Texas, 77478, United States

  • Javarra and Privia Med

    Savannah, Georgia, 31406, United States

  • Leavitt ClinResearch

    Idaho Falls, Idaho, 83404, United States

  • M3 Wake Research Inc

    Las Vegas, Nevada, 89106, United States

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612, United States

  • New Age Med Research Corp

    Miami, Florida, 33186, United States

  • OB GYN Associates of Mid Florida P.A.

    Leesburg, Florida, 34748, United States

  • PraetorianPharmaResearch LLC

    Marrero, Louisiana, 70072, United States

  • Precision Trials

    Phoenix, Arizona, 85032, United States

  • SEC Clinical Research

    Dothan, Alabama, 36305, United States

  • Seattle Clinical Research Center

    Seattle, Washington, 98104, United States

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761, United States

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001, United States

  • Spotlight Research Center

    Miami, Florida, 33176, United States

  • Stephenville Medical and Surgical Clinic

    Stephenville, Texas, 76401, United States

  • Tidewater Clinical Research

    Norfolk, Virginia, 23052, United States

  • Valley OBGYN Clinic PC

    Saginaw, Michigan, 48602, United States

  • Velocity Clinical Research

    Mobile, Alabama, 36608, United States

  • Velocity Clinical Research

    Phoenix, Arizona, 85006, United States

  • Velocity Clinical Research

    Covington, Louisiana, 70433, United States

  • Velocity Clinical Research

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research

    Beachwood, Ohio, 44122, United States

  • Velocity Clinical Research New Orleans

    New Orleans, Louisiana, 70119, United States

  • Velocity Clinical Research Santa Ana

    Huntington Park, California, 90255, United States

  • WR-Medical Center For Clinical Research

    San Diego, California, 92120, United States

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84102, United States

  • Women's Health Care Research Corp

    San Diego, California, 92111, United States

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho, 83404, United States

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