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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Female Contraception
• Intervention / Treatment: Drug: Transdermal system containing 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

• Study Type: Interventional
• Enrollment (Estimated): 1630
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Dothan, Alabama, United States, 36305
      • SEC Clinical Research
    • Mobile, Alabama, United States, 36608
      • AMR Mobile
    • Mobile, Alabama, United States, 36608
      • Velocity Clinical Research
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials
    • Phoenix, Arizona, United States, 85006
      • Velocity Clinical Research
  • California
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research Santa Ana
    • Los Angeles, California, United States, 90017
      • Essential Access Health
    • San Diego, California, United States, 92111
      • Women's Health Care Research Corp
    • San Diego, California, United States, 92120
      • WR-Medical Center For Clinical Research
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Leesburg, Florida, United States, 34748
      • OB GYN Associates of Mid Florida P.A.
    • Miami, Florida, United States, 33176
      • Spotlight Research Center
    • Miami, Florida, United States, 33173
      • Genoma Research Group
    • Miami, Florida, United States, 33186
      • New Age Med Research Corp
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare, LLC
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
  • Georgia
    • Decatur, Georgia, United States, 30030
      • CenExel iResearch LLC
    • Savannah, Georgia, United States, 31405
      • CenExel Savannah
    • Savannah, Georgia, United States, 31406
      • Javarra and Privia Med
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Women's Healthcare Associates P.A.
    • Idaho Falls, Idaho, United States, 83404
      • Leavitt ClinResearch
  • Kansas
    • Newton, Kansas, United States, 67114
      • AMR Newton
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • AMR Lexington
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management, LLC
    • Covington, Louisiana, United States, 70433
      • Velocity Clinical Research
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research
    • Marrero, Louisiana, United States, 70072
      • PraetorianPharmaResearch LLC
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates
    • New Orleans, Louisiana, United States, 70119
      • Velocity Clinical Research New Orleans
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Valley OBGYN Clinic PC
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Velocity Clinical Research
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research
    • Las Vegas, Nevada, United States, 89106
      • M3 Wake Research Inc
    • Las Vegas, Nevada, United States, 89113
      • Essential Women's Health
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • CenExel Hassman Research Institute
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Bosque Women's Care
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinic Trials Inc
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc.
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Velocity Clinical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research Philadelphia
  • Texas
    • Euless, Texas, United States, 76040
      • Cedar Health Research, LLC
    • Fort Worth, Texas, United States, 76104
      • Helios Clinical Research
    • Frisco, Texas, United States, 75033
      • ACRC Trials
    • Houston, Texas, United States, 77074
      • Clinical Trial Network LLC
    • Houston, Texas, United States, 77054
      • Javara
    • Rowlett, Texas, United States, 75088
      • Javara
    • Stephenville, Texas, United States, 76401
      • Stephenville Medical and Surgical Clinic
    • Sugarland, Texas, United States, 77478
      • Javara
    • Weatherford, Texas, United States, 76086
      • Helios Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Wasatch Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • AMR Norfolk
    • Norfolk, Virginia, United States, 23052
      • Tidewater Clinical Research
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: This is a single-arm study.; 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; MR-130A-01 transdermal system, patch to be used for female contraception

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	13 cycles [of 4 weeks (28 days)
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).	13 cycles [of 4 weeks (28 days)
Cycle-wise and cumulative pregnancy rates over 1 year	Assessment of cycle-wise and cumulative pregnancy rates over 1 year using life table analysis.	13 cycles [of 4 weeks (28 days)
Method failure PI	Assessment of method failure PI.	13 cycles [of 4 weeks (28 days)
Incidence of adverse events and serious adverse events	Assessment of adverse events and serious adverse events.	13 cycles [of 4 weeks (28 days)
Incidence of application site reactions	Assessment of application site reactions.	13 cycles [of 4 weeks (28 days)
Unscheduled bleeding	Assessment of number of episode and days of unscheduled bleeding, proportion of participants reporting unscheduled bleeding.	13 cycles [of 4 weeks (28 days)
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.	13 cycles [of 4 weeks (28 days)
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.	5 cycles [of 4 weeks (28 days)

Collaborators and Investigators

• Sponsor: Mylan Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Female, Contraception, Progestin, Transdermal, Patch; Prevent Pregnancy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins
• Other Study ID Numbers: MR-130A-01-TD-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No