MR-100A-01 for Birth Control

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Birth ControlMR-100A-01 - Drug
Eligibility
Any Age
Female
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 12 months (13 cycles)

12 months (13 cycles)
Adhesion performance as measured by adhesion scores [patch adhesion]
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
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]
Incidence of adverse events (AEs) [safety and tolerability]
Incidence of application site reactions [safety and tolerability]
Incidence of serious adverse events (SAEs) [safety and tolerability]
Method failure Pearl Index (PI) [secondary efficacy]
Number of days of scheduled and unscheduled bleeding [cycle control]
Number of episodes of scheduled and unscheduled bleeding [cycle control]
Proportion of subjects reporting scheduled and unscheduled bleeding [cycle control]

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Levora
6%Cervical dysplasia
6%Nausea
4%Upper respiratory infection
4%Nasopharyngitis
3%Sinusitis
1%Murine Typhus
1%Convulsion
1%Sinus Congestion
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT01236768) in the Levora ARM group. Side effects include: Cervical dysplasia with 6%, Nausea with 6%, Upper respiratory infection with 4%, Nasopharyngitis with 4%, Sinusitis with 3%.

Trial Design

1 Treatment Group

MR-100A-01
1 of 1

Experimental Treatment

1200 Total Participants · 1 Treatment Group

Primary Treatment: MR-100A-01 · No Placebo Group · Phase 3

MR-100A-01
Drug
Experimental Group · 1 Intervention: MR-100A-01 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months (13 cycles)

Who is running the clinical trial?

Mylan Technologies Inc.Lead Sponsor
Mylan Inc.Industry Sponsor
62 Previous Clinical Trials
19,488 Total Patients Enrolled

Eligibility Criteria

Age Any Age · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to understand and voluntarily provide written informed consent or assent to participate in the study.
You have regular menstrual cycles that are between 21 and 35 days.
You agree not to use other contraceptives or other methodology to prevent pregnancy during the study.
All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.