MR-100A-01 for Birth Control

Phase 3

Waitlist Available

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

No Placebo-Only Group

Pivotal Trial

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.

Who is the study for?

Healthy women who are at least 16 years old, have regular menstrual cycles, and want to avoid pregnancy for at least a year. They must be willing to risk pregnancy, not use other contraceptives or methods to prevent it during the study, and live within 150 miles of the research site. Women under 18 can join if local laws allow them to consent to sexual intercourse and clinical trials.

What is being tested?

The trial is testing MR-100A-01's ability as a birth control method over up to 13 menstrual cycles in about 1200 women. It will assess how effective it is at preventing pregnancy, its impact on menstrual cycle regularity, safety profile, and overall tolerability.

What are the potential side effects?

While specific side effects of MR-100A-01 aren't listed here, common side effects of contraceptive drugs may include nausea, headaches, mood changes, breast tenderness, weight gain and possible skin reactions where the product is applied.

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 weeks9 visits

Treatment ~ 13 months9 visits

Follow Up ~ 14 days3 visits

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