What to expect.
Clinical trial for women’s birth control pill now enrolling
You may be eligible to take part in medical research.
Those who qualify may receive:
Study-related care from local doctors at no cost
Study medication at no cost
Reimbursement for study-related time and travel
There is no obligation, so see if you may qualify now.
What is the Birth-Control Study?
Oral contraceptives, also known as birth control pills, or simply “the pill,” are a common choice for preventing pregnancy. Some pills are combined oral contraceptive (COC) pills. COCs use a combination of 2 hormones, estrogen, and progestogen (progesterone), to stop a woman from ovulating (releasing an egg) each month.
This study is looking at whether the investigational COC works to prevent pregnancy and is safe in women of all body types. The COC in this study is investigational because although it has already been approved for use in over 50 countries, including those in the European Union since 2011, it has not yet been approved by regulatory authorities in the United States.
Clinical trials like this one have made it possible for women and their partners to have options when choosing a form of birth control. However, because not all the options are right for everyone, it is important to keep expanding the choices available for all types of women.
Although each woman is unique, this study is hoping to provide a possible birth control option that may work for many in the future.
Approximately 2,680 women up to 35 years of age, from across the United States will be screened for the Study, and about 1,878 women are expected to receive the investigational COC. It is estimated that approximately 35% of women in the study will be overweight (have a body mass index [BMI] ≥30 kg/m2). All eligible participants in the study will be provided with the investigational COC to take, once a day, for up to 1 year.
Several tests and assessments will be performed to monitor participants’ health. These will include:
Questionnaires and interviews about medical history
Physical, gynecological, and breast examinations
Measurements of vital signs (blood pressure and heart rate), and weight and height
Electronic diary (e-Diary) completion and review (the e-Diary can be downloaded as an application to a smartphone)
CTN's Birth-Control Study is split into 3 parts:
1: A screening period
(about 6 weeks)
You will have 2 visits to make sure the study is right for you. At Visit 1 you will download an electronic diary (e-Diary) application to your smartphone (if you do not have a device, one will be provided). It is important to complete the e-Diary daily, to answer questions about your vaginal bleeding. At Visit 2, you will be given the investigational medication to start taking at home.
2: A study treatment period
(about 1 year)
You will have at least 4 study center visits and 5 phone calls with a member of the study team. You will take the investigational medication once a day and use the e-Diary to keep track of your daily medication use and daily vaginal bleeding. Once a month, you will use the e-Diary before the start of each cycle to record if you had vaginal sexual intercourse with a male partner if you used other methods of contraception, and the result of your home pregnancy test.
3: Follow-up period
(about 2 weeks)
You will visit the study center once about 2 weeks after stopping the investigational medication. You will continue to use your e-Diary until your final visit.
You may be eligible to participate in the following study if you:
are 35 years of age or younger at the onset of study participation
are having vaginal sexual intercourse with a male partner at least once a month
do not wish to become pregnant within the next year
have a history of regular menstrual cycles of 21 to 35 days prior to the use of any hormonal contraceptive.
You must meet all other study criteria to take part in the study.
Eligible participants will need to visit the study center at least 7 times over a period of up to 14 months. There will also be times they need to speak by telephone to the study team.