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Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06672016•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.

Detailed 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

Eligibility

Age

16 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+10 more criteria

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

Key Dates

Start Date

January 13, 2025

Primary Completion Date

March 1, 2027

Completion Date

April 1, 2027

Last Updated

February 24, 2026

Enrollment

1,500

ESTIMATED participants

Conditions

Female Contraception

Interventions

Transdermal system containing progestin

DRUG

Contacts

Sandeep Jagtap Director, Global Clinical Strategy

CONTACT

+49 (0) 6172-888-01 Sandeep.Jagtap@viatris.com

Keri Vaughan Head of NA Clinical Operations

CONTACT

(724) 514-1800 Keri.Vaughan@viatris.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy

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