E4 FREEDOM Birth Control Pill Study – Ages 18-50

STUDY BASICS

Are you a sexually active heterosexual woman aged 18-50 years old? If so, you may be able to participate in a research study to help test a new birth control pill. The study involves seven visits over one year. Compensation provided.

STUDY PURPOSE

Birth control pills (also called oral contraceptives) are a common birth control method. Combination birth control pills include two ingredients: estrogen, which contributes to contraceptive activity and causes menstrual cycles to occur regularly; and progestin, which prevents the release of the egg from the ovary (ovulation). Birth control pills come in many different formulations. The investigational birth control pill in this study includes an estrogen called estetrol and a progestin called drospirenone. Estetrol is a natural sex hormone produced by the human fetus during pregnancy. The estetrol used in this study is a synthetic (manmade) form and has not been used before in a contraceptive drug. Drospirenone is widely used in available contraceptive pills. The purpose of this study is to help researchers find out if an investigational combination birth control pill that includes estetrol and drospirenone can prevent pregnancy. Researchers also want more information about the overall safety and side effects of the pill. Investigational means the drug is still being tested in research studies and has not been approved for sale in the United States by the U.S. Food and Drug Administration (FDA).

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-50
• Sexually active
• Willing to rely on a study birth control pill for contraception
• Good physical and mental health
• Non-smoker if over age 35

WHAT PARTICIPANTS CAN EXPECT

Participation in this study involves seven in-person visits, and includes physical and gynecological exams, STD and pregnancy testing, and blood draws. Participants may also choose to take part in an optional sub-study that requires having extra blood taken at two visits to measure the amount of the study drug in the blood. All participants will receive the investigational birth control pills. Participants will take one study pill per day, every day for 13 menstrual cycles (approximately 1 year), and will complete a daily diary to record pill intake and other information.