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

Last updated: April 15, 2025
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

    Active - Recruiting

  • SEC Clinical Research

    Dothan, Alabama 36305
    United States

    Active - Recruiting

  • AMR Mobile

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Precision Trials

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Velocity Clinical Research Santa Ana

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Essential Access Health

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • AMR Fort Myers

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Active - Recruiting

  • OB GYN Associates of Mid Florida P.A.

    Leesburg, Florida 34748
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Spotlight Research Center

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Sensible Healthcare, LLC

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • Innovation Medical Research Center

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Clinical Research Center of Florida

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • Javarra and Privia Med

    Savannah, Georgia 31406
    United States

    Active - Recruiting

  • Leavitt ClinResearch

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • AMR Newton

    Newton, Kansas 67114
    United States

    Active - Recruiting

  • AMR Lexington

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Clinical Trials Management, LLC

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Covington, Louisiana 70433
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Lafayette, Louisiana 70508
    United States

    Active - Recruiting

  • PraetorianPharmaResearch LLC

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • Southern Clinical Research Associates

    Metairie, Louisiana 70001
    United States

    Active - Recruiting

  • Velocity Clinical Research New Orleans

    New Orleans, Louisiana 70119
    United States

    Active - Recruiting

  • Valley OBGYN Clinic PC

    Saginaw, Michigan 48602
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

  • Essential Women's Health

    Las Vegas, Nevada 89113
    United States

    Active - Recruiting

  • CenExel Hassman Research Institute

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • Albuquerque Clinic Trials Inc

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Bosque Women's Care

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • M3 Wake Research, Inc.

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Beachwood, Ohio 44122
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Cedar Health Research, LLC

    Euless, Texas 76040
    United States

    Active - Recruiting

  • Helios Clinical Research

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • ACRC Trials

    Frisco, Texas 75033
    United States

    Active - Recruiting

  • Clinical Trial Network LLC

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Javara

    Houston, Texas 77054
    United States

    Active - Recruiting

  • Javara

    Rowlett, Texas 75088
    United States

    Active - Recruiting

  • Stephenville Medical and Surgical Clinic

    Stephenville, Texas 76401
    United States

    Active - Recruiting

  • Javara

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • Helios Clinical Research

    Weatherford, Texas 76086
    United States

    Active - Recruiting

  • Wasatch Clinical Research

    Salt Lake City, Utah 84102
    United States

    Active - Recruiting

  • AMR Norfolk

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Seattle Clinical Research Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.