There are many types of prescription birth control options that women can utilize to help prevent pregnancy. This can include an injection, pill, implant, patch, or intrauterine device (IUD), with most of these birth control options containing hormones.
Miudella (mye-yoo-DE-lah) was approved in 2025 and is a nonhormonal IUD that is made of copper that is used to help prevent pregnancy for up to three years. It does not protect against sexually transmitted infections (STIs) or HIV.
How Does It Work?
Miudella is inserted into an organ called the uterus, which sits above your vagina. Your ovaries are located on both sides of your uterus and produce an egg every month. If the egg becomes fertilized, this leads to pregnancy. If the egg does not become fertilized, your uterus lining sheds, which leads to a period.
Miudella is a T-shaped system made of a thin flexible material called nitinol, which also has copper attached to it. Toward the bottom of the Miudella are two pieces of thread that extend into the vagina. Unlike a tampon string, the thread does not extend outside of your body.
The copper in Miudella prevents sperm from reaching or fertilizing the egg in your uterus. This helps prevent pregnancy. It does not stop your ovaries from making an egg.
How Do I Use It?
You will schedule an appointment with your health care provider to have Miudella inserted into your uterus. Your health care provider will insert Miudella into your uterus through a skinny plastic tube. Miudella starts to work as soon as it is inserted.
After you have had Miudella inserted into your uterus, check to make sure it is in place by feeling for the thread ends inside your vagina at least once a month. To do this, wash your hands with soap and water. Then reach up to the top of your vagina with your fingers to feel the two thread ends.
Be careful not to accidentally pull on the thread ends, as this can cause Miudella to move out of place. If you do not feel the thread ends, feel changes in the length of the thread ends, or feel any other part of Miudella besides the thread ends, call your health care provider right away. If Miudella is not in the right position, it may not protect against pregnancy. Avoid having sex if you can or use a backup contraception method such as a condom or spermicide until your health care provider determines if Miudella is in the right place. Make sure to keep all follow-up appointments with your health care provider. Your health care provider may check to make sure Miudella is in the right place.
If it has been three years and you would still like to prevent pregnancy with Miudella, your health care provider can remove Miudella and replace it with a new Miudella.
Miudella is a reversible birth control, meaning your ability to get pregnant will go back to whatever is normal for you once Miudella is removed. If you would like to stop using Miudella, you can talk to your health care provider about removing it. If you do not want to become pregnant, it is important to use another type of birth control. Talk to your health care provider about this, if possible, before having Miudella removed. In some cases, depending on the type of birth control option used, you may need to start using the alternative birth control for some time before having Miudella removed.
How Was It Studied?
One clinical study was conducted to test the safety and effectiveness of Miudella for pregnancy prevention over three years. The study included people aged 17 to 45 years old who were capable of becoming pregnant. The study included White Americans (74%), Hispanic or Latino (19%), African Americans (15%), Asian Americans (5%), Native Americans or Alaska Natives (1%), and Native Hawaiians (<1%). About 4% of people were classified as more than one race and less than 1% of people were classified as “Unknown.” The average age of people in the study was 28 years old.
What Benefits Were Seen?
The pregnancy risk of people using Miudella was about 1% over the course of three years. This was based on 22 reported pregnancies over 27,115 menstrual cycles.
What Are The Side Effects and How Can I Manage Them?
You may experience pelvis pain or discomfort, bleeding, or dizziness during and after placement of Miudella. If any of these occur, your health care provider may ask you to lie down until you feel better. Contact your health care provider if these symptoms are severe or do not go away.
Additional side effects can include heavy bleeding during your period, painful periods, bleeding or spotting between periods, and pain during sex. Heavy bleeding during your periods and spotting between periods should normally go away after you have used Miudella for the first few months. Call your health care provider if this has not gone away. You may also experience anemia, which is a low red blood cell count, which can cause dizziness. You may also experience irritation or discharge of your vagina, back pain, or cramping. Call your health care provider if these symptoms do not go away.
If you are experiencing back pain or cramping, using heating pads may help. Talk to your health care provider to see if keeping certain over-the-counter medicines on hand may help.
Call your health care provider right away if you become pregnant. If you get pregnant while using Miudella, you may have a higher risk of developing an ectopic pregnancy, which is when a pregnancy happens outside of the uterus. Signs of this are unusual vaginal bleeding or stomach pain, especially with missed periods. Ectopic pregnancy is a medical emergency that may require surgery. It can cause bleeding, infertility, and death if not treated. There may also be additional risks if a typical pregnancy occurs within the uterus and you still have Miudella in place. This can include infections, miscarriage, or premature delivery.
What Else Should I Be Aware Of?
You can use tampons and pads with Miudella, but you cannot use a menstrual cup or disc, as this may cause Miudella to shift to an incorrect position. You and your partner should not feel Miudella during sex. If your partner feels the thread ends or if you or your partner experience pain during sex, call your health care provider. Before having any medical procedures or imaging such as a magnetic resonance imaging (MRI) or diathermy, tell your health care provider that you have Miudella in place. There may be certain procedures or imaging that you can and cannot get done while using Miudella.
How Can I Learn More?
You can learn more about Miudella by visiting www.sebelapharma.com/miudella or by calling the manufacturer at 866-246-2133. You can also talk to your health care provider.
