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RECRUITING

NCT06672016

PHASE3

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

Sponsor: Mylan Pharmaceuticals Inc

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Multicenter, Open-Label, Single-Arm Study of MR-130A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety

Key Details

Gender

FEMALE

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2025-01-13

Completion Date

2027-04

Last Updated

2026-02-24

Healthy Volunteers

Conditions

Female Contraception

Interventions

DRUG

Transdermal system containing progestin

MR-130A-01 transdermal system, patch to be used for female contraception

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.

Locations (57)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

SEC Clinical Research

Dothan, Alabama, United States

AMR Mobile

Mobile, Alabama, United States

Velocity Clinical Research

Mobile, Alabama, United States

Velocity Clinical Research

Phoenix, Arizona, United States

Precision Trials

Phoenix, Arizona, United States

Velocity Clinical Research Santa Ana

Huntington Park, California, United States

Essential Access Health

Los Angeles, California, United States

Women's Health Care Research Corp

San Diego, California, United States

WR-Medical Center For Clinical Research

San Diego, California, United States

AMR Fort Myers

Fort Myers, Florida, United States

Altus Research

Lake Worth, Florida, United States

OB GYN Associates of Mid Florida P.A.

Leesburg, Florida, United States

Genoma Research Group

Miami, Florida, United States

Spotlight Research Center

Miami, Florida, United States

New Age Med Research Corp

Miami, Florida, United States

Sensible Healthcare, LLC

Ocoee, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

Clinical Research Center of Florida

Pompano Beach, Florida, United States

CenExel iResearch LLC

Decatur, Georgia, United States

CenExel Savannah

Savannah, Georgia, United States

Javarra and Privia Med

Savannah, Georgia, United States

Leavitt ClinResearch

Idaho Falls, Idaho, United States

Women's Healthcare Associates P.A.

Idaho Falls, Idaho, United States

AMR Newton

Newton, Kansas, United States

AMR Lexington

Lexington, Kentucky, United States

Clinical Trials Management, LLC

Covington, Louisiana, United States

Velocity Clinical Research

Covington, Louisiana, United States

Velocity Clinical Research

Lafayette, Louisiana, United States

PraetorianPharmaResearch LLC

Marrero, Louisiana, United States

Southern Clinical Research Associates

Metairie, Louisiana, United States

Velocity Clinical Research New Orleans

New Orleans, Louisiana, United States

Valley OBGYN Clinic PC

Saginaw, Michigan, United States

Velocity Clinical Research

Gulfport, Mississippi, United States

Alliance for Multispecialty Research

Kansas City, Missouri, United States

M3 Wake Research Inc

Las Vegas, Nevada, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Essential Women's Health

Las Vegas, Nevada, United States

CenExel Hassman Research Institute

Marlton, New Jersey, United States

Albuquerque Clinic Trials Inc

Albuquerque, New Mexico, United States

Bosque Women's Care

Albuquerque, New Mexico, United States

M3 Wake Research, Inc.

Raleigh, North Carolina, United States

Velocity Clinical Research

Beachwood, Ohio, United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania, United States

Cedar Health Research, LLC

Euless, Texas, United States

Helios Clinical Research

Fort Worth, Texas, United States

ACRC Trials

Frisco, Texas, United States

Javara

Houston, Texas, United States

Clinical Trial Network LLC

Houston, Texas, United States

Javara

Rowlett, Texas, United States

Stephenville Medical and Surgical Clinic

Stephenville, Texas, United States

Javara

Sugarland, Texas, United States

Helios Clinical Research

Weatherford, Texas, United States

Wasatch Clinical Research

Salt Lake City, Utah, United States

Tidewater Clinical Research

Norfolk, Virginia, United States

AMR Norfolk

Norfolk, Virginia, United States

Seattle Clinical Research Center

Seattle, Washington, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)