Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential

Last updated: February 20, 2026
Sponsor: Mylan Pharmaceuticals Inc
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Transdermal system containing progestin

Clinical Study ID

NCT06672016
MR-130A-01-TD-3001
  • Ages > 16
  • Female

Study Summary

The Sponsor is developing a progestin-only contraceptive transdermal system (patch).

The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated.

The study patch is a transdermal system that contains the active ingredient, progestin.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are atleast 16 years of age.

  2. Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1year.

  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 durationover the last 6 months.

  5. Engages in regular heterosexual vaginal intercourse (at least once per cycle), witha partner who is not known to be sub fertile or infertile.

  6. Agrees not to use other contraceptives or other methodology to prevent pregnancyduring the study.

  7. Able to understand and voluntarily provide written informed consent or assent (ifthe participant is adolescent prior to undergoing any trial related procedure) toparticipate in the study.

Exclusion

Exclusion Criteria:

  1. Known or suspected pregnancy or planning pregnancy during next 12 months.

  2. Participants with known hypersensitivity or intolerance to progestins, or anycomponents of the progestin patch.

  3. History or presence of dermal sensitivity to medicated patches or to topicalapplications including bandages, surgical tape.

  4. Known infertility (current or known history) or history of sterilization in eitherpartner.

  5. Received injectable hormonal contraceptive therapy within 10 months of studyenrollment.

  6. Current use of hormonal contraceptive implants.

  7. Has non-hormonal or hormonal intrauterine device (IUD) in place; or has had a recentIUD removal without one spontaneous menses after removal prior to the date ofenrollment.

  8. Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal orcesarean delivery.

  9. Participants lactating at the time of screening into the study or has occurrence ofless than 3 regular menstrual cycles after cessation of lactation.

  10. Anticipates routine use of condoms or any other form of back-up contraception forprotection from sexually transmitted infections during the study or for emergencycontraception.

  11. Participants having a known contraindication to progestin-only contraception.

  12. Known or suspected progestin sensitive malignant or premalignant conditionsincluding 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 inducersor 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 liverfunction 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 bleedingwhich is expected to recur during the study.

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: Transdermal system containing progestin
Phase: 3
Study Start date:
January 13, 2025
Estimated Completion Date:
April 30, 2027

Study Description

Unintended pregnancy continues to be a significant reproductive health problem worldwide. Although the increase in the availability of longer-acting contraceptive methods has improved the situation, the continuing development of newer safe and effective contraception is crucial for women's health.

The development of a progestin-only contraceptive with more convenient dosing may provide women with additional options. The investigational patch is intended to provide an option for women who may not be able to use estrogen-containing combined hormonal contraceptives

Connect with a study center

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • SEC Clinical Research

    Dothan, Alabama 36305
    United States

    Site Not Available

  • AMR Mobile

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Velocity Clinical Research

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Alabama Clinical Therapeutics, LLC

    Birmingham 4049979, Alabama 4829764 35235
    United States

    Active - Recruiting

  • SEC Clinical Research

    Dothan 4059102, Alabama 4829764 36305
    United States

    Active - Recruiting

  • AMR Mobile

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Mobile 4076598, Alabama 4829764 36608
    United States

    Active - Recruiting

  • Precision Trials

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Precision Trials

    Phoenix 5308655, Arizona 5551752 85032
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Velocity Clinical Research Santa Ana

    Huntington Park, California 90255
    United States

    Site Not Available

  • Essential Access Health

    Los Angeles, California 90017
    United States

    Site Not Available

  • WR-Medical Center For Clinical Research

    San Diego, California 92120
    United States

    Active - Recruiting

  • Women's Health Care Research Corp

    San Diego, California 92111
    United States

    Site Not Available

  • Velocity Clinical Research Santa Ana

    Huntington Park 5358736, California 5332921 90255
    United States

    Active - Recruiting

  • Essential Access Health

    Los Angeles 5368361, California 5332921 90017
    United States

    Active - Recruiting

  • WR-Medical Center For Clinical Research

    San Diego 5391811, California 5332921 92120
    United States

    Active - Recruiting

  • Women's Health Care Research Corp

    San Diego 5391811, California 5332921 92111
    United States

    Active - Recruiting

  • AMR Fort Myers

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • OB GYN Associates of Mid Florida P.A.

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Clinical Investigator Site

    Miami, Florida 33186
    United States

    Site Not Available

  • Genoma Research Group

    Miami, Florida 33173
    United States

    Active - Recruiting

  • New Age Med Research Corp

    Miami, Florida 33186
    United States

    Site Not Available

  • Spotlight Research Center

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Sensible Healthcare, LLC

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Site Not Available

  • AMR Fort Myers

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Altus Research

    Lake Worth 4161422, Florida 4155751 33461
    United States

    Active - Recruiting

  • OB GYN Associates of Mid Florida P.A.

    Leesburg 4161771, Florida 4155751 34748
    United States

    Active - Recruiting

  • Genoma Research Group

    Miami 4164138, Florida 4155751 33173
    United States

    Active - Recruiting

  • New Age Med Research Corp

    Miami 4164138, Florida 4155751 33186
    United States

    Active - Recruiting

  • Spotlight Research Center

    Miami 4164138, Florida 4155751 33176
    United States

    Active - Recruiting

  • Sensible Healthcare, LLC

    Ocoee 4166776, Florida 4155751 34761
    United States

    Active - Recruiting

  • Innovation Medical Research Center

    Palmetto Bay 4167634, Florida 4155751 33157
    United States

    Active - Recruiting

  • Clinical Research Center of Florida

    Pompano Beach 4169014, Florida 4155751 33060
    United States

    Site Not Available

  • Javarra and Privia Med

    Savannah, Georgia 31406
    United States

    Site Not Available

  • CenExel iResearch LLC

    Decatur 4191124, Georgia 4197000 30030
    United States

    Active - Recruiting

  • CenExel Savannah

    Savannah 4221552, Georgia 4197000 31405
    United States

    Active - Recruiting

  • Javarra and Privia Med

    Savannah 4221552, Georgia 4197000 31406
    United States

    Active - Recruiting

  • Leavitt ClinResearch

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Leavitt ClinResearch

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Active - Recruiting

  • Women's Healthcare Associates P.A.

    Idaho Falls 5596475, Idaho 5596512 83404
    United States

    Active - Recruiting

  • AMR Newton

    Newton, Kansas 67114
    United States

    Site Not Available

  • AMR Newton

    Newton 4276248, Kansas 4273857 67114
    United States

    Active - Recruiting

  • AMR Lexington

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • AMR Lexington

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Active - Recruiting

  • Clinical Trials Management, LLC

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Velocity Clinical Research

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • PraetorianPharmaResearch LLC

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Southern Clinical Research Associates

    Metairie, Louisiana 70001
    United States

    Site Not Available

  • Velocity Clinical Research New Orleans

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Covington 4321005, Louisiana 4331987 70433
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Covington 4321005, Louisiana 4331987 70433
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Lafayette 4330145, Louisiana 4331987 70508
    United States

    Active - Recruiting

  • PraetorianPharmaResearch LLC

    Marrero 4332628, Louisiana 4331987 70072
    United States

    Active - Recruiting

  • Southern Clinical Research Associates

    Metairie 4333177, Louisiana 4331987 70001
    United States

    Active - Recruiting

  • Velocity Clinical Research New Orleans

    New Orleans 4335045, Louisiana 4331987 70119
    United States

    Active - Recruiting

  • Valley OBGYN Clinic PC

    Saginaw, Michigan 48602
    United States

    Site Not Available

  • Valley OBGYN Clinic PC

    Saginaw 5007989, Michigan 5001836 48602
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Gulfport 4428667, Mississippi 4436296 39503
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Kansas City 4393217, Missouri 4398678 64114
    United States

    Active - Recruiting

  • Essential Women's Health

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Essential Women's Health

    Las Vegas 5506956, Nevada 5509151 89113
    United States

    Active - Recruiting

  • Excel Clinical Research

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Active - Recruiting

  • M3 Wake Research Inc

    Las Vegas 5506956, Nevada 5509151 89106
    United States

    Active - Recruiting

  • CenExel Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • CenExel Hassman Research Institute

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Active - Recruiting

  • Albuquerque Clinic Trials Inc

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Bosque Women's Care

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Albuquerque Clinic Trials Inc

    Albuquerque 5454711, New Mexico 5481136 87102
    United States

    Active - Recruiting

  • Bosque Women's Care

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Active - Recruiting

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • M3 Wake Research, Inc.

    Raleigh 4487042, North Carolina 4482348 27612
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Velocity Clinical Research

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Velocity Clinical Research

    Beachwood 5146711, Ohio 5165418 44122
    United States

    Active - Recruiting

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Clinical Research Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Euless, Texas 76040
    United States

    Site Not Available

  • Helios Clinical Research

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • ACRC Trials

    Frisco, Texas 75033
    United States

    Site Not Available

  • Clinical Trial Network LLC

    Houston, Texas 77074
    United States

    Site Not Available

  • Javara

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Javara

    Rowlett, Texas 75088
    United States

    Site Not Available

  • Stephenville Medical and Surgical Clinic

    Stephenville, Texas 76401
    United States

    Site Not Available

  • Javara

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Helios Clinical Research

    Weatherford, Texas 76086
    United States

    Site Not Available

  • Cedar Health Research, LLC

    Euless 4689550, Texas 4736286 76040
    United States

    Active - Recruiting

  • Helios Clinical Research

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Active - Recruiting

  • ACRC Trials

    Frisco 4692559, Texas 4736286 75033
    United States

    Active - Recruiting

  • Clinical Trial Network LLC

    Houston 4699066, Texas 4736286 77074
    United States

    Active - Recruiting

  • Javara

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • Javara

    Rowlett 4724194, Texas 4736286 75088
    United States

    Active - Recruiting

  • Stephenville Medical and Surgical Clinic

    Stephenville 4734350, Texas 4736286 76401
    United States

    Active - Recruiting

  • Javara

    Sugarland, Texas 4736286 77478
    United States

    Active - Recruiting

  • Helios Clinical Research

    Weatherford 4740364, Texas 4736286 76086
    United States

    Active - Recruiting

  • Wasatch Clinical Research

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Wasatch Clinical Research

    Salt Lake City 5780993, Utah 5549030 84102
    United States

    Active - Recruiting

  • AMR Norfolk

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • AMR Norfolk

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Active - Recruiting

  • Tidewater Clinical Research

    Norfolk 4776222, Virginia 6254928 23052
    United States

    Active - Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Seattle Clinical Research Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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