ContraceptionPhase 3NCT05139121
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
A Phase 3 study testing MR-100A-01 in people with Contraception, run by Mylan Technologies Inc. at 100 sites in 3 countries.
Trial summary
Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- MR-100A-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 100 sitesin 3 countries
- Study dates
- 26 Oct 2021to 15 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- 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 with no upper age limit. Post-menarcheal female subjects who are at risk of pregnancy, and <18 years are eligible provided that:
- Applicable national, state, and local laws allow the subject to consent to sexual intercourse,
- Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
- All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
- 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.
Show all 14Show fewer
- Has normal, regular menstrual cycles that are between 21 and 35 days.
- Engages in regular heterosexual vaginal intercourse.
- 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 to participate in the study.
- Able to understand and willing to be compliant with study procedures.
- Willing to accept a risk of pregnancy.
- Has demonstrated ability to complete e-Diary.
- Planning to reside within a reasonable driving/ public transport distance of the research site (approximately 150 miles) for around 12 months (13 cycles).
Who cannot join
- Known or suspected pregnancy or planning pregnancy during next 12 months.
- Subjects with known hypersensitivity or intolerance to estrogens, progestins, or any components of the MR-100A-01 product.
- History or presence of dermal sensitivity 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 or has had less than 2 consecutive, spontaneous menses after an injectable hormonal contraceptive was received at least 10 months earlier.
- Current use of hormonal contraceptive implants (still implanted; or if an implant was removed, less than 3 consecutive spontaneous menses have occurred between removal and enrollment).
Show all 45Show 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 and have had less than 3 consecutive, spontaneous menses or withdrawal bleeding episodes prior to enrollment.
- Subjects lactating at the time of screening into the study.
- 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.
- Subjects having a known contraindication to combined hormonal contraception as listed below:
- Smoker who is ≥35 years old.
- History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs), valvular heart disease with complications (pulmonary hypertension, risk for atrial fibrillation, or history of subacute bacterial endocarditis), peripartum cardiomyopathy.
- History or presence of hypertension (including adequately controlled hypertension) or hypertension with vascular disease or elevated blood pressure (BP) defined as systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, measured in sitting position after 5 minutes of rest, considering the average of two readings measured 1 to 2 minutes apart
- History or presence of deep vein thrombosis/pulmonary embolism (DVT/PE) or superficial venous thrombosis.
- Has any comorbid condition that may require major surgery with prolonged immobilization during the study period.
- Subjects with known inherited or acquired hypercoagulopathy.
- History or presence of systemic lupus erythematosus.
- History or presence of neurological conditions including migraine with aura at any age, migraine without aura in women ≥35 years age or in women who smoke, or multiple sclerosis with prolonged immobility.
- History or presence of or suspected carcinoma of breast.
- Has diabetes mellitus with nephropathy, retinopathy, neuropathy, or other vascular disease or diabetes of >20 years' duration.
- Has inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are at increased risk for VTE
- Medically treated or presence of symptomatic gall bladder disease.
- History of combined hormonal contraceptive/pregnancy-related cholestasis/jaundice.
- Presence of liver disease.
- History of organ transplantation within 5 years before screening or chronic disease potentially necessitating organ transplantation during the anticipated course of the study.
- Subject has requirement to be on treatment with medications prohibited during study.
- Known or suspected estrogen or progestin sensitive malignant or premalignant conditions.
- History of any other condition that in the Investigator's opinion suggests an elevated risk of arterial or venous thromboembolic disease.
- Has uncontrolled thyroid disorder.
- Has diagnosis of hereditary angioedema.
- Has hyperlipidemia on screening.
- Has uncontrolled diabetes mellitus.
- Subjects with abnormal significant liver function tests.
- Has a significantly abnormal cervical cancer screening test (cervical cytology with reflex human-papilloma-virus (HPV) testing or with HPV co-testing) performed at screening visit (for subjects aged ≥21 years) i.e., cervical dysplasia or invasive cervical cancer or has any abnormal cytology with/without HPV testing during 6 months prior to screening which may require additional screening or treatment during the study period
- Subjects with chlamydial or gonorrheal infection.
- Has unexplained vaginal bleeding.
- History of known or suspected hepatitis B or C infection or high risk for sexually transmitted disease (STD).
- Known human immunodeficiency virus (HIV) infection or positive confirmatory test at screening.
- Current known active infection of coronavirus disease 2019 (COVID-19) or increased risk of COVID-19 related morbidity. Subjects who have had previous COVID-19 infections but have recovered by the time of enrollment visit may be enrolled if there are no current COVID-19 symptoms; Subjects who had previously received COVID-19 vaccine may be enrolled irrespective of the timing of the vaccination.
- Within the past year, either history of suicidal ideation or attempt or severe depression requiring hospitalization.
- Presence of any other concomitant disease or laboratory result that may worsen under hormonal treatment based on Investigator's discretion.
- Positive urine drug screen.
- Recent history (within prior 12 months) of drug or alcohol abuse or at Investigator discretion, history greater than 12 months prior and at risk for noncompliance. Current or recent history of (recreational or medicinal) marijuana use is not exclusionary at the investigator's discretion upon assessment of any potential risk.
- Participation in an investigational study within 30 days prior to enrollment or intention to participate within next 13 months.
Trial locations and contacts
100 sites in 3 countries.
100 sites in 3 countries
United States96 sites
Velocity Clinical Research- Albuquerque
Albuquerque, New Mexico, 87107
Bosque Women's Care
Albuquerque, New Mexico, 87109
Agile Clinical Research Trials
Atlanta, Georgia, 30342
Medisense Inc.
Atlanta, Georgia, 30363
Alliance Research Institute
Bell Gardens, California, 90201
Essential Access Health
Berkeley, California, 94710
Quantum Clinical Trials
Boynton Beach, Florida, 33435
New York Clinical Trials - Brooklyn
Brooklyn, New York, 11201
Velocity Clinical Research-Charleston
Charelston, South Carolina, 29414
Javara Inc. Tryon Medical-South Park
Charlotte, North Carolina, 28210
Chattanooga Medical Research LLC
Chattanooga, Tennessee, 37404
Javara Inc/Privia Medical Group, LLC
Chevy Chase, Maryland, 20815
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
Velocity Clinical Research, Cleveland
Cleveland, Ohio, 44122
Clinical Trials Management
Covington, Louisiana, 70433
Velocity Clinical Research - Covington
Covington, Louisiana, 70433
DCT-HCWC, LLC dba Discovery Clinical Trials
Dallas, Texas, 75230
CenExel iResearch Atlanta, LLC
Decatur, Georgia, 30030
Soapstone Center for Clinical Research
Decatur, Georgia, 30033-3500
Physicians' Research Options, LLC Corner Canyon Clinic
Draper, Utah, 84020
Aventiv Research - Columbus
Dublin, Ohio, 43016
Carolina Women's Research And Wellness Center
Durham, North Carolina, 27713
Ob/Gyn Associates Of Erie
Erie, Pennsylvania, 16507
SBL Special Services
Frederick, Maryland, 21702
Aventura OB/GYN Associates
Hallandale, Florida, 33009
CenExel RCA
Hollywood, Florida, 33024
Global Research Associates
Homestead, Florida, 33030
Velocity Clinical Research - Huntington Park
Huntington Park, California, 90255
Cedar Health Research
Irving, Texas, 75251
UF Health Woman's Specialist - Emerson
Jacksonville, Florida, 32207
Alliance for Multispecialty Research, LLC.
Knoxville, Tennessee, 37920
Multi-Specialty Research Associates
Lake City, Florida, 32055
WR-Multi-Specialty Research Associates LLC
Lake City, Florida, 32055
Altus Research
Lake Worth, Florida, 33461
Red Rocks Ob-Gyn
Lakewood, Colorado, 80228
Excel Clinical Research
Las Vegas, Nevada, 89109
Office of Edmond Pack, MD
Las Vegas, Nevada, 89113
Wake Research Clinical Research Center of Nevada - Emergency Medicine
Las Vegas, Nevada, 89123
Ob-Gyn Associates Of Mid-Florida, PA
Leesburg, Florida, 34748
Essential Access Health
Los Angeles, California, 90010
Axis Clinical Trials
Los Angeles, California, 90036
Matrix Clinical Research
Los Angeles, California, 90057
Velocity Clinical Research - Gardena
Los Angeles, California, 90057
Velocity Clinical Research, Panorama City
Los Angeles, California, 90057
Hassman Research Institute
Marlton, New Jersey, 08053
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 70072
WR-Medical Research Center of Memphis, LLC.
Memphis, Tennessee, 38120
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
Mesa Obstetricians and Gynecologists.
Mesa, Arizona, 85206
Velocity Clinical Research Metairie
Metairie, Louisiana, 70006
Advanced Pharma CR LLC
Miami, Florida, 33147
Avantis Clinical Research
Miami, Florida, 33155
AdMed Research, LLC
Miami, Florida, 33173
New Age Medical Research Corporation
Miami, Florida, 33186
ProCare Research Center, Corp.
Miami Gardens, Florida, 33014
Global Health Research Center
Miami Lakes, Florida, 33016
Planned Parenthood of Minnesota
Minneapolis, Minnesota, 55408
Mobile Ob-Gyn, P.C.
Mobile, Alabama, 36608
Velocity Clinical Research
Mobile, Alabama, 36608
Venus Gynecology, LLC.
Myrtle Beach, South Carolina, 29572-4177
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Columbia University Medical Center
New York, New York, 10032
Tidewater Clinical Research/TPW
Norfolk, Virginia, 23502
Eastern Virginia Medical School, Clinical Research Center
Norfolk, Virginia, 23507
Healthcare Clinical Data, Inc. - Segal Institute for Clinica
North Miami, Florida, 33161
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Clintheory Healthcare Miami
Orlando, Florida, 32819
Stanford University, School of Medicine, Department of Obstetrics and Gynecology
Palo Alto, California, 94304
Advances In Health, Inc.
Pearland, Texas, 77584
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
Precision Trials AZ
Phoenix, Arizona, 85032
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213-3180
Physicians' Research Options, LLC
Pleasant Grove, Utah, 84062
Empire Clinical Research
Pomona, California, 91767
Oregon Health & Science University Center for Women's Health
Portland, Oregon, 97201
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina, 27607
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Virginia Women's Health Associates
Reston, Virginia, 20192
Northern California Research Corp
Sacramento, California, 95821
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Women's Health Care Research Corp.
San Diego, California, 92111
Wr-McCr, Llc
San Diego, California, 92120
Amicis Research Center
San Fernando, California, 91340
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
Physician Care Clinical Research
Sarasota, Florida, 34239
CenExel iResearch, LLC
Savannah, Georgia, 31405
Fellows Research Alliance, Inc.
Savannah, Georgia, 31406
Seattle Clinical Research Center
Seattle, Washington, 98105
Montefiore Medical Center
The Bronx, New York, 10461
Visions Clinical Research Tucson
Tucson, Arizona, 85712
IntimMedicine Specialists
Washington D.C., District of Columbia, 20036
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, 84088
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Upstate Clinical Research Associates
Williamsville, New York, 14221
Unified Women's Clinical Research d/b/a Lyndhurst Clinical R
Winston-Salem, North Carolina, 27103
Canada3 sites
Centricity Research Quebec City
Lévis, Quebec, G6W 0M5
Clinique RSF Inc.
Québec, Quebec, G1V 3M7
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 6P6
About this study
Official title: A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles
Read the detailed description
MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg. This study will evaluate the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01.
- Conditions
- Contraception
- Being tested
- MR-100A-01
- Keywords
- Birth Control, Pregnancy Prevention, Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-100A-01Drug
Also called Transdermal contraceptive delivery system
Transdermal contraceptive delivery system
| Study group | Role | What they receive |
|---|---|---|
| MR-100A-01 | Experimental | MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol. Transdermal contraceptive delivery system to be applied every 7 days for 3 consecutive weeks followed by a 1-week patch free period Receives: Drug: MR-100A-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Efficacy of MR-100A-01 When Used Over Thirteen 28-day Cycles in Healthy, Post-menarcheal, Premenopausal, Heterosexually Active Female Subjects of Childbearing Potential Who Are at Least 16 Years of Age and at Risk of Pregnancy
The Pearl Index, defined as the number of pregnancies per 100 women years, was calculated as: Pearl Index = (1300×number of on-treatment pregnancies)/number of evaluable cycles.
Evaluable cycles were defined as the complete or incomplete 28-day cycles in which vaginal intercourse occurred and in which no back-up contraception was used based on the electronic diary data, unless a pregnancy occurred in such a cycle.
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Secondary outcomes (9)
Cumulative Probability of Pregnancy at the End of Cycle 13
Cumulative pregnancy rates over 1 year evaluated using life table analysis
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Method Failure Pearl Index (PI)
The method failure PI is defined as PI among all complete or incomplete on therapy cycles in which intercourse occurred and protocol guidelines for patch applications were appropriately followed and without any major protocol deviations
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Incidence of Treatment Emergent Adverse Events (TEAEs)
A summary of the count and percentage of subjects (2%) reporting a TEAE
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Incidence of Serious Adverse Events (SAEs)
A summary of count and percentage of subjects reporting a Treatment emergent SAE
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Participants Reported Application Site Disorder
Number of participants reported Application site disorder which were treatment emergent adverse events (TEAE)
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Days of Unscheduled Bleeding/and or Spotting
The observed number of days of unscheduled bleeding/and or spotting
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Bleeding and/or Spotting Episodes
Number of Bleeding and/or Spotting episodes
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Proportion of Subjects Reporting Unscheduled Bleeding/and or Spotting Episodes
Incidences (percentage of subjects) of unscheduled bleeding and/or spotting episodes within each cycle
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Adhesion Performance as Measured by Adhesion Scores [Patch Adhesion]
The descriptive figures of adhesion performance reported by subjects in their e-Diary on all days except during the patch-free week on the following 5-point scale.
Score 0 indicates best adhesion and score 4 indicates worst adhesion. Higher score indicates poor adhesion.
Self-Reported Scoring System of Patch Adhesion Assessment
Score 0 - The patch has essentially no lift off the skin (≥90% adhered) Score 1 - Only some edges of the patch lift off the skin (≥75% to <90% adhered) Score 2 - Less than half of the patch lifts off the skin (≥50% to <75% adhered) Score 3 - The patch is not detached, but more than half of it lifts off the skin without falling off (>0% to <50% adhered) Score 4 - The patch is detached and is completely off the skin (0% adhered)
Measured: approximately 12 months (13 cycles with each cycle for 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start26 Oct 2021
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mylan Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139121
- Sponsor's protocol ID
- MR-100A-01-TD-3001
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2021
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05139121
- Acronym / sponsor ID
- MR-100A-01-TD-3001
- Conditions
- Contraception
- Keywords
- Birth Control, Pregnancy Prevention, Contraceptive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,320 participants (actual)
- Lead sponsor
- Mylan Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mylan Inc.
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 14 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approxmiately 1200 women for up to 13 cycles
Detailed description
MR-100A-01 is a TDS of norelgestromin 4.86 mg/ethinyl estradiol 0.264 mg. This study will evaluate the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-100A-01 | Experimental | Drug: MR-100A-01MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol. Transdermal contraceptive delivery system to be applied every 7 days for 3 consecutive weeks followed by a 1-week patch free period |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy, post-menarcheal and premenopausal women at risk of pregnancy who are at least 16 years of age with no upper age limit. Post-menarcheal female subjects who are at risk of pregnancy, and <18 years are eligible provided that:
- 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.
- Engages in regular heterosexual vaginal intercourse.
Key exclusion criteria (45 listed)
- Known or suspected pregnancy or planning pregnancy during next 12 months.
- Subjects with known hypersensitivity or intolerance to estrogens, progestins, or any components of the MR-100A-01 product.
- History or presence of dermal sensitivity 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 or has had less than 2 consecutive, spontaneous menses after an injectable hormonal contraceptive was received at least 10 months earlier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-100A-01Also: Transdermal contraceptive delivery systemTransdermal contraceptive delivery system | Drug | MR-100A-01 |
Primary outcome
Contraceptive Efficacy of MR-100A-01 When Used Over Thirteen 28-day Cycles in Healthy, Post-menarcheal, Premenopausal, Heterosexually Active Female Subjects of Childbearing Potential Who Are at Least 16 Years of Age and at Risk of Pregnancy
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
The Pearl Index, defined as the number of pregnancies per 100 women years, was calculated as: Pearl Index = (1300×number of on-treatment pregnancies)/number of evaluable cycles. Evaluable cycles were defined as the complete or incomplete 28-day cycles in which vaginal intercourse occurred and in which no back-up contraception was used based on the electronic diary data, unless a pregnancy occurred in such a cycle.
9 secondary outcomes
Cumulative Probability of Pregnancy at the End of Cycle 13
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Method Failure Pearl Index (PI)
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Incidence of Serious Adverse Events (SAEs)
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Participants Reported Application Site Disorder
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Days of Unscheduled Bleeding/and or Spotting
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Number of Bleeding and/or Spotting Episodes
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Proportion of Subjects Reporting Unscheduled Bleeding/and or Spotting Episodes
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Adhesion Performance as Measured by Adhesion Scores [Patch Adhesion]
Time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
100 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MR-100A-01 in people with Contraception, run by Mylan Technologies Inc. at 100 sites in 3 countries.
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 14 inclusion and 45 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Canada, Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Contraceptive Efficacy of MR-100A-01 When Used Over Thirteen 28-day Cycles in Healthy, Post-menarcheal, Premenopausal, Heterosexually Active Female Subjects of Childbearing Potential Who Are at Least 16 Years of Age and at Risk of Pregnancy (time frame: approximately 12 months (13 cycles with each cycle for 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.