Join a clinical study looking at a progestin-only birth control patch for women
The Empower Study is looking at an investigational progestin-only contraceptive patch for healthy, sexually active women with a body mass index (BMI) of at least 30 kg/m2.
People who take part may receive*:
- Study-related care from local doctors at no cost
- Study patch at no cost
- Reimbursement for reasonable study-related time and travel
There is no obligation, so see if you may qualify now.
What is the Empower Study?
The Empower Study is looking at an investigational progestin-only contraceptive (birth control) patch, called the “study patch.” The study is looking at the study patch, which is applied to the skin weekly, to see:
- whether it works to prevent pregnancy in healthy, sexually active women
- how safe it is
- how the body handles it, called “tolerability.”
A patch may be an alternative for women who cannot or prefer not to take medicine by mouth daily. A patch is also less invasive than other forms of progestin-only contraceptives such as injections, implants, or intrauterine devices.
Many contraceptives work by releasing the hormones estrogen and progesterone into the body. However, some women cannot take estrogen-containing contraceptives if they have a higher BMI, are breastfeeding, or are at risk of developing blood clots and other health conditions. The study patch contains progestin, which is a specific form of progesterone that is made in a laboratory. There is a need for additional forms of progestin-only contraceptives for women who cannot use or choose not to use estrogen.
What to expect
About 1500 women from the United States will join this study. If you take part, you will have 7 visits to the study center and 9 phone calls with the study team.
Some participants will also have pharmacokinetic (PK) testing, which is where blood samples will be taken to check levels of progesterone in your blood.
At study center visits, several tests and assessments will be performed to monitor your health. These will include:
The study will last up to 15 months.
1
Screening period
(7 to 60 days)
You will visit the study center to see if the study is suitable for you and whether you want to take part. You will also start completing an electronic diary (eDiary).
2
Enrollment visit
You will have a study center visit to check if you can continue in the study about 2 weeks before you start using the study patch.
3
Study treatment period
(about 1 year)
During the study treatment period, you will apply the study patch to the skin like a band-aid once every 7 days for about 1 year. There are 13 treatment cycles, and each treatment cycle lasts for 28 days. There is no patch-free week. You will complete the eDiary every day as instructed and record the date and time of every study patch application.
4
End of study (EOS) visit
You will have an EOS visit at the study center 7 days after you remove the last study patch. If you stop using the study patch early for any reason, you will also have an EOS visit.
What is a clinical research study?
A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a potential new (investigational) medication. Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about a potential new medication, such as:
- How safe is the potential new medication?
- Does it work?
What is a potential new medication?
A potential new (investigational) medication, also sometimes called an investigational drug or a study medication, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. An investigational medication also may be a medication that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. An investigational medication can only be used in clinical research studies.
All potential new medications must be tested in clinical research studies before they can be approved by health regulatory authorities to be prescribed to patients. We need people to take part in clinical research studies so that new medications can be developed.
After reading all the information on this website, I still have questions about trying a potential new medication that may not work. Can you give me more information?
There are always risks and benefits of participating in a clinical research study. There is always a chance that the potential new (investigational) medication could cause side effects or will not work. However, you should know that there are strict rules in place to monitor the safety of people taking part in a study. Before joining any clinical research study, it is important to consider the risks and understand them.
The study team will explain all the risks and benefits at the first study visit. Throughout the study, a team of doctors and nurses will monitor the health of the people taking part. They will be there to answer any questions you may have.
What happens after a decision is made to take part in the study?
If you would like to know whether you might be able to take part in the study, please fill out the form. You will be told immediately if the study is a good match. If you pre-qualify, we will connect you to a clinical research study center in your area. We will also help schedule the first study appointment at the study center. Please note: During the screening process, the study doctor or study team will check additional criteria before someone can join the study.
Is there a cost to take part?
The study-required potential new (investigational) medication (study patch) will be provided at no cost. The person taking part in the study will also receive study-related care from a team of experienced doctors and nurses throughout the study at no cost.
Will participant confidentiality be protected?
All personal information will remain confidential, and data will only be collected and used as necessary to support an individual’s match to and participation in a study. Participants’ names will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.
Are clinical research studies safe?
Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.
Participating in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants can take as much time as they need to decide whether to take part and get as much information as they can. Before joining a study, the potential study participant will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.
What else should someone thinking about taking part in a clinical study consider?
It is a personal decision to take part. Participation in the study is voluntary. Please also consider:
- If a decision is made to participate, you can withdraw at any time during the study.
- The study team will explain the possible benefits and risks of the study during the informed consent process.
- A person does not have to join any study if they don’t want to.
- A team of doctors and nurses will carefully monitor the health of people taking part during the study.
- The potential new (investigational) medication (study patch) will be provided at no cost.
- Taking part in the study may help other women looking for more suitable contraceptive options in the future.
People taking part in the study will need to follow all the instructions from the study doctor and nurses.
See If You Pre-Qualify
