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Contraceptive

MR-100A-01 for Birth Control

Phase 3
Recruiting
Research Sponsored by Mylan Technologies Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has negative UPT results at screening and at enrollment visits.
Has normal, regular menstrual cycles that are between 21 and 35 days.
Timeline
Screening 28 weeks
Treatment 13 months
Follow Up 14 days
Awards & highlights

Summary

This trial is studying a birth control patch called MR-100A-01 in women. The patch contains hormones that prevent pregnancy by stopping ovulation and making it harder for sperm to reach eggs. The study will look at how well the patch works, how it affects menstrual cycles, and its safety and tolerability. The MR-100A-01 patch is similar to other transdermal contraceptive patches that have been studied for their effectiveness in preventing ovulation and controlling menstrual cycles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You do not want to become pregnant and plan to use hormonal birth control for at least a year.
Select...
Has regular sex with someone of the opposite gender.

Timeline

Screening ~ 28 weeks
Treatment ~ 13 months
Follow Up ~14 days
This trial's timeline: 28 weeks for screening, 13 months for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Adhesion performance as measured by adhesion scores [patch adhesion]
Cumulative pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]
Cycle-wise pregnancy rates over 1 year evaluated using life table analysis [secondary efficacy]
+7 more

Side effects data

From 2011 Phase 3 trial • 407 Patients • NCT01236768
6%
Cervical dysplasia
5%
Nasopharyngitis
4%
Sinusitis
4%
Sinus Congestion
3%
Nausea
2%
Upper respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
AG200-15
Levora

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR-100A-01Experimental Treatment1 Intervention
MR-100A-01 is a transdermal delivery system designed to deliver daily hormone exposure of Norelgestromin and Ethinyl Estradiol

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Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Mylan Technologies Inc.Lead Sponsor
Mylan Inc.Industry Sponsor
62 Previous Clinical Trials
19,513 Total Patients Enrolled
~313 spots leftby Sep 2025
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