Clinical Research Details

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

Study Description

This is a study to learn the effectiveness of an investigational drug to prevent pregnancy, the safety and tolerability of wearing the patch. Healthy female participants of childbearing potential and at least 18 years old who agree to be in this study will receive the transdermal patches containing norelgestromin and ethinyl estradiol. Participants will undergo a screening period of 7 to 60 days that include blood and urine tests, physical and gynecological exams. Participants will be required to complete a total of 7 clinic visits, 9 phone contacts during study treatment, and daily entry into the e-Diary. A urine pregnancy test will be performed at each clinic visit. The total time of a participant's participation in this study will be about 1 year, for a total of thirteen 28-day cycles.

Inclusion/Exclusion Criteria

Women in need of contraception that would be willing to use this investigational patch for one year.


Andrew M. Kaunitz, M.D., FACOG
Obstetrics and Gynecology

Courtney P. Rhoades, D.O., M.B.A.
Obstetrics and Gynecology