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Evaluating a progestin-only contraceptive patch for women

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

Phase 3 Interventional Viatris Inc. · NCT06672016

This study tests a new skin patch that uses progestin to see if it can safely help women aged 16 and older prevent pregnancy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1500 (estimated)
Ages16 Years and up
SexFemale
SponsorViatris Inc. Industry-sponsored
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT06672016 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a new progestin-only transdermal contraceptive patch designed for women of childbearing potential. It aims to determine how well the patch prevents pregnancy and how well it is tolerated by participants. The study includes healthy women aged 16 and older who wish to avoid pregnancy and are seeking hormonal contraception for at least one year. Participants will be monitored for their menstrual cycles and overall health during the trial.

Who should consider this trial

Good fit: Ideal candidates are healthy, premenopausal women aged 16 and older who are at risk of pregnancy and desire hormonal contraception.

Not a fit: Patients who are pregnant, planning to become pregnant, or have a known hypersensitivity to progestin will not benefit from this study.

Why it matters

Potential benefit: If successful, this patch could provide a new, convenient contraceptive option for women who cannot use estrogen-containing methods.

How similar studies have performed: Other studies have shown success with similar hormonal contraceptive methods, indicating a potential for this approach to be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Female ContraceptionFemale, Contraception, Progestin, Transdermal, PatchPrevent Pregnancy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.