Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential
NCT ID: NCT06672016
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1500 participants
INTERVENTIONAL
2025-01-13
2027-04-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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
Transdermal system containing progestin
MR-130A-01 transdermal system, patch to be used for female contraception
Interventions
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Transdermal system containing progestin
MR-130A-01 transdermal system, patch to be used for female contraception
Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
FEMALE
No
Sponsors
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Mylan Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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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
AMR Fort Myers
Fort Myers, Florida, United States
Altus Research
Lake Worth, Florida, United States
OB GYN Associates of Mid Florida P.A.
Leesburg, Florida, United States
Genoma Research Group
Miami, Florida, United States
Spotlight Research Center
Miami, Florida, United States
New Age Med Research Corp
Miami, Florida, United States
Sensible Healthcare, LLC
Ocoee, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Javarra and Privia Med
Savannah, Georgia, United States
Leavitt ClinResearch
Idaho Falls, Idaho, United States
Women's Healthcare Associates P.A.
Idaho Falls, Idaho, United States
AMR Newton
Newton, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
Clinical Trials Management, LLC
Covington, Louisiana, United States
Velocity Clinical Research
Covington, Louisiana, United States
Velocity Clinical Research
Lafayette, Louisiana, United States
PraetorianPharmaResearch LLC
Marrero, Louisiana, United States
Southern Clinical Research Associates
Metairie, Louisiana, United States
Velocity Clinical Research New Orleans
New Orleans, Louisiana, United States
Valley OBGYN Clinic PC
Saginaw, Michigan, United States
Alliance for Multispecialty Research
Kansas City, Missouri, United States
Essential Women's Health
Las Vegas, Nevada, United States
CenExel Hassman Research Institute
Marlton, New Jersey, United States
Albuquerque Clinic Trials Inc
Albuquerque, New Mexico, United States
Bosque Women's Care
Albuquerque, New Mexico, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Velocity Clinical Research
Beachwood, Ohio, United States
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States
Cedar Health Research, LLC
Euless, Texas, United States
Helios Clinical Research
Fort Worth, Texas, United States
ACRC Trials
Frisco, Texas, United States
Javara
Houston, Texas, United States
Clinical Trial Network LLC
Houston, Texas, United States
Javara
Rowlett, Texas, United States
Stephenville Medical and Surgical Clinic
Stephenville, Texas, United States
Javara
Sugarland, Texas, United States
Helios Clinical Research
Weatherford, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
AMR Norfolk
Norfolk, Virginia, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Countries
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Central Contacts
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Sandeep Jagtap Director, Global Clinical Strategy
Role: CONTACT
Facility Contacts
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Other Identifiers
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MR-130A-01-TD-3001
Identifier Type: -
Identifier Source: org_study_id
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