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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

Study Summary

This trial is testing a new contraceptive pill, MR-100A-01, to see if it is effective, safe, and well-tolerated by women.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please share how many hospitals are taking part in this research?

"There are 46 sites enrolling patients for this clinical trial, which is testing a new cancer treatment. Patients enrolled in the study will be asked to visit the clinic nearest to them for treatments and follow-up visits."

Answered by AI

What health risks have been associated with MR-100A-01?

"There is evidence from previous trials to support the efficacy of MR-100A-01 as well as data collected from multiple rounds of testing that affirms its safety. Consequently, our team has rated it a 3 on our scale."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Tennessee
Georgia
Other
What site did they apply to?
Mylan Investigator Site
Healthcare Clinical Data, Inc. - Segal Institute for Clinica
Chattanooga Medical Research LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
2

Why did patients apply to this trial?

I don't want any kids at the moment. I am open to trying new birth control options. I have two boys very close in age and am always looking for a new and safer birth control method.
PatientReceived 2+ prior treatments
I’m in the market for birth control, and I’m always curious about new options. I have 2 children and am no longer interested in growing my family.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Mylan Investigator Site: < 24 hours
  2. Chattanooga Medical Research LLC: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles
2021. "Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139121.
~343 spots leftby Apr 2025
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