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Female ContraceptionPhase 3NCT06672016

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

A Phase 3 study testing Transdermal system containing progestin in people with Female Contraception, run by Mylan Pharmaceuticals Inc at 56 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Female Contraception
What is being tested?
Transdermal system containing progestin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,630 participants
Where
56 sitesUnited States
Study dates
13 Jan 2025to May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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).
  • Has diagnosis of hereditary angioedema.
  • Participants with abnormal significant liver function tests as measured by liver function tests
  • Has a significantly abnormal cervical cancer screening test.
  • Participants with chlamydial or gonorrheal infection at screening.
  • Has unexplained vaginal bleeding within the past 6 months or any abnormal bleeding which is expected to recur during the study.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

United States56 sites

  • Albuquerque Clinic Trials Inc

    Albuquerque, New Mexico, 87102

  • Bosque Women's Care

    Albuquerque, New Mexico, 87109

  • Velocity Clinical Research

    Beachwood, Ohio, 44122

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Clinical Trials Management, LLC

    Covington, Louisiana, 70433

  • Velocity Clinical Research

    Covington, Louisiana, 70433

  • CenExel iResearch LLC

    Decatur, Georgia, 30030

  • SEC Clinical Research

    Dothan, Alabama, 36305

  • Cedar Health Research, LLC

    Euless, Texas, 76040

  • Helios Clinical Research

    Fort Worth, Texas, 76104

  • ACRC Trials

    Frisco, Texas, 75033

  • Velocity Clinical Research

    Gulfport, Mississippi, 39503

  • Javara

    Houston, Texas, 77054

  • Clinical Trial Network LLC

    Houston, Texas, 77074

  • Velocity Clinical Research Santa Ana

    Huntington Park, California, 90255

  • Leavitt ClinResearch

    Idaho Falls, Idaho, 83404

  • Women's Healthcare Associates P.A.

    Idaho Falls, Idaho, 83404

  • Alliance for Multispecialty Research

    Kansas City, Missouri, 64114

  • Velocity Clinical Research

    Lafayette, Louisiana, 70508

  • Altus Research

    Lake Worth, Florida, 33461

  • M3 Wake Research Inc

    Las Vegas, Nevada, 89106

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Essential Women's Health

    Las Vegas, Nevada, 89113

  • OB GYN Associates of Mid Florida P.A.

    Leesburg, Florida, 34748

  • AMR Lexington

    Lexington, Kentucky, 40509

  • Essential Access Health

    Los Angeles, California, 90017

  • CenExel Hassman Research Institute

    Marlton, New Jersey, 08053

  • PraetorianPharmaResearch LLC

    Marrero, Louisiana, 70072

  • Southern Clinical Research Associates

    Metairie, Louisiana, 70001

  • Genoma Research Group

    Miami, Florida, 33173

  • Spotlight Research Center

    Miami, Florida, 33176

  • New Age Med Research Corp

    Miami, Florida, 33186

  • AMR Mobile

    Mobile, Alabama, 36608

  • Velocity Clinical Research

    Mobile, Alabama, 36608

  • Velocity Clinical Research New Orleans

    New Orleans, Louisiana, 70119

  • AMR Newton

    Newton, Kansas, 67114

  • Tidewater Clinical Research

    Norfolk, Virginia, 23052

  • AMR Norfolk

    Norfolk, Virginia, 23502

  • Sensible Healthcare, LLC

    Ocoee, Florida, 34761

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Velocity Clinical Research

    Phoenix, Arizona, 85006

  • Precision Trials

    Phoenix, Arizona, 85032

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • Javara

    Rowlett, Texas, 75088

  • Valley OBGYN Clinic PC

    Saginaw, Michigan, 48602

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84102

  • Women's Health Care Research Corp

    San Diego, California, 92111

  • WR-Medical Center For Clinical Research

    San Diego, California, 92120

  • CenExel Savannah

    Savannah, Georgia, 31405

  • Javarra and Privia Med

    Savannah, Georgia, 31406

  • Seattle Clinical Research Center

    Seattle, Washington, 98104

  • Stephenville Medical and Surgical Clinic

    Stephenville, Texas, 76401

  • Javara

    Sugarland, Texas, 77478

  • Helios Clinical Research

    Weatherford, Texas, 76086

Other trials in United States

About this study

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

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.

Read the 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

Being tested
Transdermal system containing progestin
Keywords
Female, Contraception, Progestin, Transdermal, Patch, Prevent Pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transdermal system containing progestinDrug

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

Study groups in NCT06672016
Study groupRoleWhat they receive
This is a single-arm study.ExperimentalThe 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
Receives: Drug: Transdermal system containing progestin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 13 cycles [of 4 weeks (28 days)

Secondary outcomes (9)

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

    Assessment of PI in obese population (Body mass index (BMI) ≥30.0 kg/m2).

    Measured: 13 cycles [of 4 weeks (28 days)

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

    Assessment of PI in non-obese population (BMI <30.0 kg/m2).

    Measured: 13 cycles [of 4 weeks (28 days)

  3. Cycle-wise and cumulative pregnancy rates over 1 year

    Assessment of cycle-wise and cumulative pregnancy rates over 1 year using life table analysis.

    Measured: 13 cycles [of 4 weeks (28 days)

  4. Method failure PI

    Assessment of method failure PI.

    Measured: 13 cycles [of 4 weeks (28 days)

  5. Incidence of adverse events and serious adverse events

    Assessment of adverse events and serious adverse events.

    Measured: 13 cycles [of 4 weeks (28 days)

  6. Incidence of application site reactions

    Assessment of application site reactions.

    Measured: 13 cycles [of 4 weeks (28 days)

  7. Unscheduled bleeding

    Assessment of number of episode and days of unscheduled bleeding, proportion of participants reporting unscheduled bleeding.

    Measured: 13 cycles [of 4 weeks (28 days)

  8. Adhesion performance

    Assessment of patch adhesion performance as measured by 'Self-Reported Scoring System of Patch Adhesion Assessment Scale' Scores range from 0 to 4 where score 0 indicates the patch has essentially no lift off the skin and score 4 indicates the patch is detached and is completely off the skin.

    Measured: 13 cycles [of 4 weeks (28 days)

  9. progestin plasma concentrations

    Evaluation of progestin exposure in the subset of participants. PK samples for evaluation of progestin concentrations will be collected during cycles 2 and 5, for population PK and exposure-response analysis.

    Measured: 5 cycles [of 4 weeks (28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start13 Jan 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,630 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06672016
Sponsor's protocol ID
MR-130A-01-TD-3001
Status last verified
Oct 2026
First submitted
28 Oct 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Transdermal system containing progestin in people with Female Contraception, run by Mylan Pharmaceuticals Inc at 56 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the contraceptive efficacy of progestin only patch when used over 13 cycles (time frame: 13 cycles [of 4 weeks (28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06672016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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