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

NCT06672016 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MR-130A-01-TD-3001
• Study Type: interventional
• Target: 1,630
• Locations: 1 country
• Sites: 56

Brief 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.

Conditions

Female Contraception

Keywords

Female, Contraception, Progestin, Transdermal, Patch; Prevent Pregnancy

Outcome Measures

Primary Outcomes (1)

• To determine the contraceptive efficacy of progestin only patch when used over 13 cycles

  The primary efficacy endpoint will be pregnancy rate described by Pearl Index (PI). PI is defined as the number of pregnancies per 100 women-years.

  13 cycles [of 4 weeks (28 days)

Secondary Outcomes (9)

• To determine the efficacy in obese population (Body mass index (BMI) ≥30.0 kg/m2)

  13 cycles [of 4 weeks (28 days)

• To determine the efficacy in non-obese population (Body mass index (BMI) <30.0 kg/m2)

  13 cycles [of 4 weeks (28 days)

• Cycle-wise and cumulative pregnancy rates over 1 year

  13 cycles [of 4 weeks (28 days)

• Method failure PI

  13 cycles [of 4 weeks (28 days)

• Incidence of adverse events and serious adverse events

  13 cycles [of 4 weeks (28 days)

Study Arms (1)

This is a single-arm study.

EXPERIMENTAL

The study patch is a transdermal system that contains the active ingredient progestin. This study is an open-label, single-arm study. This means that all participants in the study will receive the study patch

Drug: Transdermal system containing progestin

Interventions

Transdermal system containing progestin DRUG

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

This is a single-arm study.

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age.
• Desires to avoid pregnancy, is seeking to use hormonal contraception for at least 1 year.
• Has negative UPT results at screening and at enrollment visits.
• Has normal, regular menstrual cycles that are between 21 and 35 days in duration over the last 6 months.
• Engages in regular heterosexual vaginal intercourse (at least once per cycle), with a partner who is not known to be sub fertile or infertile.
• Agrees not to use other contraceptives or other methodology to prevent pregnancy during the study.
• 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.

You may not qualify if:

• Known or suspected pregnancy or planning pregnancy during next 12 months.
• Participants with known hypersensitivity or intolerance to progestins, or any components of the progestin patch.
• History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape.
• Known infertility (current or known history) or history of sterilization in either partner.
• Received injectable hormonal contraceptive therapy within 10 months of study enrollment.
• Current use of hormonal contraceptive implants.
• 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.
• Recent surgical or medical abortion, miscarriage, ectopic pregnancy, or vaginal or cesarean delivery.
• Participants lactating at the time of screening into the study or has occurrence of less than 3 regular menstrual cycles after cessation of lactation.
• 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.
• Participants having a known contraindication to progestin-only contraception.
• Known or suspected progestin sensitive malignant or premalignant conditions including but not limited to carcinoma of endometrium, ovary, or fallopian tubes.
• Skin abnormality (e.g., tattoo or scar) at all possible application sites.
• Long-term treatment with drugs or herbal products that are moderate/strong inducers or inhibitors of CYP3A4.
• Has uncontrolled thyroid disorder (thyrotoxicosis or myxedema).

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (56)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

SEC Clinical Research

Dothan, Alabama, 36305, United States

Location

AMR Mobile

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research

Phoenix, Arizona, 85006, United States

Location

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Velocity Clinical Research Santa Ana

Huntington Park, California, 90255, United States

Location

Essential Access Health

Los Angeles, California, 90017, United States

Location

Women's Health Care Research Corp

San Diego, California, 92111, United States

Location

WR-Medical Center For Clinical Research

San Diego, California, 92120, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

OB GYN Associates of Mid Florida P.A.

Leesburg, Florida, 34748, United States

Location

Genoma Research Group

Miami, Florida, 33173, United States

Location

Spotlight Research Center

Miami, Florida, 33176, United States

Location

New Age Med Research Corp

Miami, Florida, 33186, United States

Location

Sensible Healthcare, LLC

Ocoee, Florida, 34761, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

CenExel iResearch LLC

Decatur, Georgia, 30030, United States

Location

CenExel Savannah

Savannah, Georgia, 31405, United States

Location

Javarra and Privia Med

Savannah, Georgia, 31406, United States

Location

Leavitt ClinResearch

Idaho Falls, Idaho, 83404, United States

Location

Women's Healthcare Associates P.A.

Idaho Falls, Idaho, 83404, United States

Location

AMR Newton

Newton, Kansas, 67114, United States

Location

AMR Lexington

Lexington, Kentucky, 40509, United States

Location

Clinical Trials Management, LLC

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research

Lafayette, Louisiana, 70508, United States

Location

PraetorianPharmaResearch LLC

Marrero, Louisiana, 70072, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Velocity Clinical Research New Orleans

New Orleans, Louisiana, 70119, United States

Location

Valley OBGYN Clinic PC

Saginaw, Michigan, 48602, United States

Location

Velocity Clinical Research

Gulfport, Mississippi, 39503, United States

Location

Alliance for Multispecialty Research

Kansas City, Missouri, 64114, United States

Location

M3 Wake Research Inc

Las Vegas, Nevada, 89106, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Essential Women's Health

Las Vegas, Nevada, 89113, United States

Location

CenExel Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Albuquerque Clinic Trials Inc

Albuquerque, New Mexico, 87102, United States

Location

Bosque Women's Care

Albuquerque, New Mexico, 87109, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Velocity Clinical Research

Beachwood, Ohio, 44122, United States

Location

Clinical Research Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Cedar Health Research, LLC

Euless, Texas, 76040, United States

Location

Helios Clinical Research

Fort Worth, Texas, 76104, United States

Location

ACRC Trials

Frisco, Texas, 75033, United States

Location

Javara

Houston, Texas, 77054, United States

Location

Clinical Trial Network LLC

Houston, Texas, 77074, United States

Location

Javara

Rowlett, Texas, 75088, United States

Location

Stephenville Medical and Surgical Clinic

Stephenville, Texas, 76401, United States

Location

Javara

Sugarland, Texas, 77478, United States

Location

Helios Clinical Research

Weatherford, Texas, 76086, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84102, United States

Location

Tidewater Clinical Research

Norfolk, Virginia, 23052, United States

Location

AMR Norfolk

Norfolk, Virginia, 23502, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 4, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (56)