- The SECURE Study is a clinical research study of a new birth control patch.
- It will help evaluate the effectiveness and safety of an investigational transdermal contraceptive patch, called Twirla®.
- ‘Investigational’ means that the patch has not been approved by the FDA.
- ‘Transdermal’ means the hormones from the patch are absorbed through your skin.
- The study patch is a birth control method being studied for women who want to prevent pregnancy.
- The study patch is designed to be flexible, and is applied to the skin. It moves with you throughout all of your normal activities.
- The study patch contains the same type of hormones that are in many combined hormonal contraceptive pills. Their use in this study is investigational.
- Around 2000 women will take part in the SECURE Study across around 100 different sites in the USA.
- Not everyone who wants to join will be able to. Several joining criteria must be met.
- Be sexually active at least once a month.
- Need to use birth control.
- Not wish to become pregnant for at least 1 year.
- Be able to use the patch as their only form of birth control for at least 1 year.
It is voluntary to join the study and you can leave at any time and for any reason with no penalty.
What is a contraceptive patch?
The investigational contraceptive patch, Twirla®, sticks to the skin, and each patch is left in place for 1 week. The hormones from the patch are continually absorbed through the skin into the body. This is the same way that combined hormonal contraceptive pills work. They change the body’s hormone balance to:
- Stop production of an egg each month (in other words, prevent ovulation).
- Thicken the mucus in your cervix to make it difficult for sperm to pass through to the womb (uterus) to fertilize an egg.
- Make the lining of the uterus thinner so it is less favorable for implantation.
To be effective, contraceptives need to be used as instructed. If the instructions are not followed precisely, you may be at increased risk of becoming pregnant. The patch needs to be used exactly as instructed and not just when you have sex.
Why might a contraceptive patch be useful?
- The patch is designed to be a simple, convenient method of contraception that allows women to be in control.
- It is applied once a week for 3 weeks, followed by a patch-free week.
- You do not need to remember it every day.
- It is non-invasive (unlike IUDs, shots, and implants).
- It is designed to be discreet.
- It does not interfere with having sexual intercourse.
What will the study involve?
To assess whether you are eligible to join the study there will be two initial visits, a screening and a run-in visit, during which you will be asked a number of questions about your medical history and other joining criteria. You will also use an electronic diary for 2 weeks and receive 2 phone calls from the study clinic.
If you join the study, you will receive Twirla® patches over the course of 1 year, as you come in for your visits. The patches and all study check-ups will be provided at no cost to you.
- During the study, you will need to keep a daily diary of various items, such as Twirla® use, sexual activity, and vaginal bleeding. And you’ll need to attend 8 scheduled clinic visits. During these visits, we will carry out standard tests to check on your health, run pregnancy tests, and ask you questions. You will also receive 6 phone calls from the Study Team to check in on how you are doing. There may also be additional unscheduled visits or calls if necessary. Your last visit will be around 17 days after the last study patch has been removed. You will discuss with the study doctor if you would like to stay on hormonal contraception (a 3-month supply of birth control pills will be provided if you complete the study).
- If you think you might like to join the study, please contact us. We can tell you more about it and explain what participation would mean for you. We will also carry out several medical tests and talk to you about your contraceptive needs to see whether you are right for the study, and the study is right for you. We will talk through the potential benefits and risks of being involved in the study, before you make your decision about joining. It is your choice whether to join and, even if you do join, you can leave the study at any time.
What about side effects?
As with all medications, there is a possibility that you may experience side effects. The study site staff will talk with you about all known side effects and risks before you decide if you want to participate. The study doctor and team will monitor your health throughout your participation and discuss any concerns you may have.
If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of treatment, which may include discontinuation of the study patch.