European Active Surveillance Study of LCS12
This study, called EURAS-LCS12, is looking into a new intrauterine coil called LCS12. Coils are a very effective way of preventing pregnancy. Researchers want to compare how well LCS12 works to prevent unintended pregnancies against established coils like Mirena and copper IUDs. They are also checking for common side effects like ectopic pregnancies (when a pregnancy develops outside the womb), uterine perforation (a rare event where the coil pokes through the womb), and pelvic infections. The study focuses on women under 40 years old who are new users of these coils, tracking their experiences over time in real-life situations.
At a glance
What is this study about?
You might have heard of or considered using an intrauterine device (IUD), often called a coil, for contraception. These are small, T-shaped devices placed inside the womb by a doctor or nurse to prevent pregnancy. There are different types available, including hormonal coils like Mirena and non-hormonal copper coils.
This study is focusing on a newer hormonal coil called LCS12. Like Mirena, LCS12 releases a hormone to prevent pregnancy, but it's designed to be smaller. Doctors and researchers want to understand how effective LCS12 is at preventing pregnancy compared to Mirena and copper coils. They also want to see if there are any differences in side effects, such as a pregnancy happening even with the coil in place, a pregnancy developing outside the womb (ectopic pregnancy), or rare problems like the coil causing a small hole in the womb (uterine perforation) or leading to a pelvic infection.
This is an 'observational' study, meaning that doctors will simply follow women who choose to use one of these coils as part of their usual care. They won't be giving you a specific coil to try; you and your doctor will decide which coil is right for you. The study aims to gather important information from thousands of women about their experiences with these devices in everyday life, helping us understand more about how well they work and any potential concerns.
Key takeaways
- This study is comparing a new coil (LCS12) with existing coils like Mirena and copper IUDs.
- It aims to understand how well they prevent pregnancy and track side effects.
- You must be under 40 years old when your coil is inserted to join.
- Participation involves sharing your health information during your usual care, not extra visits.
- Your experiences will help improve contraception knowledge for other women.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a woman under 40 years old on the day you have your new coil inserted. This coil can be LCS12, Kyleena, Mirena, a copper IUD, or any other hormonal IUD.
It's important that you are willing to take part in the ongoing monitoring for the study as you use your coil. This means you agree to provide information about your experiences with the coil, which helps researchers understand its effectiveness and safety.
You cannot join if you are 40 years old or older when your coil is put in, or if you are already taking part in another clinical trial specifically looking into IUDs.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you under 40 years old on the day you get your new coil inserted?
- Are you getting a new coil (like LCS12, Mirena, Kyleena, or a copper IUD)?
- Are you willing to share your experiences with your coil for the study?
- Are you NOT currently in another research study about coils?
What does participation involve?
If you decide to participate, you will receive your chosen coil (LCS12, Mirena, or a copper IUD) as part of your normal healthcare. You won't be given a specific coil by the study, but rather you and your doctor will decide what's best for you. The study team will then keep track of your health and any events related to your coil over time. This is mainly to see if you become pregnant, or if you experience any of the specific side effects mentioned, like an ectopic pregnancy or an infection.
This is an 'observational' study, so it won't involve extra clinic visits specifically for research purposes beyond your routine check-ups. You'll be asked to report certain health information, which will then be confirmed by your healthcare providers. The total duration of your participation will depend on how long you use your coil and how long the study continues to collect information.
Potential risks and benefits
Locations (1)
- Center for Epidemiology and Health Research BerlinVerified postcodeBerlin, Germany
Common questions
What is an IUD or 'coil'?
An IUD, or intrauterine device, is a small, T-shaped device that a doctor or nurse places inside your womb to prevent pregnancy. There are hormonal and non-hormonal types.
What is LCS12?
LCS12 is a newer type of hormonal coil, similar to Mirena, but designed to be slightly smaller.
Will I have to take any special medication?
No, you won't be asked to take any special medication for this study. You will simply use your chosen coil as you normally would.
Will I have extra doctor's appointments?
This study doesn't ask you to have extra appointments. Your information will be gathered during your routine medical care.
What if I get pregnant while on the study?
If you become pregnant, it will be an important piece of information for the study researchers to understand how well the coil works. You should discuss your pregnancy with your healthcare provider as you normally would.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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