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Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles

A Phase 3, Multicenter, Open-Label, Single Arm Study of MR-100A-01 in Women of Childbearing Potential to Evaluate Contraceptive Efficacy and Safety

NCT05139121•Mylan Technologies Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

16 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. 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:
•1. Applicable national, state, and local laws allow the subject to consent to sexual intercourse,
•2. Applicable national, state, and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
•3. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
•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.
•5. Engages in regular heterosexual vaginal intercourse.
•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 to participate in the study.
+4 more criteria

Exclusion Criteria

•1. Known or suspected pregnancy or planning pregnancy during next 12 months.
•2. Subjects with known hypersensitivity or intolerance to estrogens, progestins, or any components of the MR-100A-01 product.
•3. History or presence of dermal sensitivity 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 or has had less than 2 consecutive, spontaneous menses after an injectable hormonal contraceptive was received at least 10 months earlier.
•6. 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).
•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 and have had less than 3 consecutive, spontaneous menses or withdrawal bleeding episodes prior to enrollment.
•9. Subjects lactating at the time of screening into the study.
•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.
+35 more criteria

Locations (100)

Mobile Ob-Gyn, P.C.

Mobile, Alabama, United States

Velocity Clinical Research

Mobile, Alabama, United States

Mesa Obstetricians and Gynecologists.

Mesa, Arizona, United States

Precision Trials AZ

Phoenix, Arizona, United States

Visions Clinical Research Tucson

Tucson, Arizona, United States

Alliance Research Institute

Bell Gardens, California, United States

Essential Access Health

Berkeley, California, United States

Velocity Clinical Research - Huntington Park

Huntington Park, California, United States

Essential Access Health

Los Angeles, California, United States

Axis Clinical Trials

Los Angeles, California, United States

Key Dates

Start Date

October 26, 2021

Primary Completion Date

January 15, 2025

Completion Date

January 15, 2025

Last Updated

January 28, 2025

Enrollment

1,319

ACTUAL participants

Conditions

Contraception

Interventions

MR-100A-01

DRUG

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

NCT06345586

Contraception

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RECRUITINGNA

Effect of Different Sex Hormone Profiles for the Response to Physical Training

NCT07115849

EumenorrheaIntrauterine Devices, Medicated+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles

Inclusion Criteria

Exclusion Criteria

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

Effect of Different Sex Hormone Profiles for the Response to Physical Training

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

Investigating Ovulation Inhibition for Use as a Contraceptive

Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults

Oral Contraceptive Pill (OCP) Pharmacogenomics