Liletta (levonorgestrel) is an intrauterine device (IUD) used to prevent pregnancy and also to treat heavy periods (menstrual bleeding).  Liletta is an IUD which is a small, flexible, T-shaped plastic device that is placed in the uterus, where it slowly releases the hormone levonorgestrel.  

The Liletta IUD works to prevent pregnancy by thickening the mucus at the entrance to the uterus to prevent sperm from entering, thinning the lining of the uterus, and preventing sperm from moving and surviving in the uterus. Liletta works to treat heavy periods by levonorgestrel effect on the uterus. Liletta works to treat heavy periods by controlling the monthly development of the uterus lining so there is less bleeding each month.

Liletta contains levonorgestrel which is a progestin hormone; it does not contain estrogen. It should not be used as emergency birth control and does not protect you from sexually transmitted infections or human immunodeficiency virus (HIV).

How long does Liletta IUD last?

Liletta can be used for up to 8 years to prevent pregnancy and for 5 years when used for heavy periods and as a contraceptive. It can be replaced at the time of removal with a new device if continued contraceptive protection is wanted. You can stop using the IUD at any time by asking your healthcare provider to remove it.

When does Liletta start working?

If you are currently not using hormonal or intrauterine contraception:

• Liletta IUD will start working immediately as a contraceptive if it is inserted within the first seven days of your period or immediately after a first-trimester abortion or miscarriage. However, if you choose to have Liletta inserted at any other time during your monthly cycle, you will need to use an additional birth control method (like condoms) for the first week, as at this stage of your cycle, it takes seven days after the insertion of Liletta for it to provide full protection against pregnancy.

For information on when Liletta starts working when switching from oral, transdermal, vaginal hormonal contraceptive or injectable progestin contraceptive, see the dosing information link below.

How well does Liletta work?

Liletta IUD is very effective at preventing pregnancy with a low chance of becoming pregnant, with less than 1 in 100 patients becoming pregnant in one year.

Liletta IUD works well to reduce heavy menstrual bleeding with 80% of patients having their blood loss reduced by half after 6 months.

Do not use Liletta during pregnancy. Tell your doctor right away if you become pregnant.

The Liletta IUD is inserted through the vagina and placed into the uterus by a healthcare professional. You may feel pain or dizziness during insertion of the IUD, and you may have minor vaginal bleeding. Tell your doctor if these symptoms last longer than 30 minutes.

Your doctor should check Liletta after a few weeks to make sure it is still in place. You will also need annual pelvic exams and Pap smears.

Liletta should not interfere with sexual intercourse, wearing a tampon or menstrual cup, or using other vaginal medications.

The IUD may come out by itself. After each menstrual period, make sure you can still feel the removal threads at the opening of your cervix. At the lower end of the Liletta device, there are two treads which are the only part of the device that you can feel when the IUD is in your uterus; however, unlike a tampon string, the threads do not extend outside your body.

Call your doctor at once if you cannot feel the strings or if you think Liletta has slipped lower or has come out of your uterus, especially if you also have pain or bleeding. Use a non-hormone method of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy until your doctor is able to replace the IUD.

You may have irregular periods for 3 to 6 months. Your flow may be lighter or heavier, and your periods may stop after several months. Tell your doctor if you do not have a period for 6 weeks or if you think you might be pregnant.

If you need to have an MRI (magnetic resonance imaging), tell your healthcare providers ahead of time that you have an IUD in place.

Liletta may be removed at any time you decide to stop using birth control. Liletta must be removed at the end of the 8-year wearing time when used as a contraceptive and for 5 years when used for heavy periods and as a contraceptive. 

If you decide to use a different method of birth control, you may need to start using it a week before Liletta is removed.

Only your doctor should remove the IUD. Do not attempt to remove the device yourself.

Liletta contains levonorgestrel 52 mg, which initially has a release rate of 20 mcg/day and declines to 6.5 mcg/day after 8 years. The average release rate of levonorgestrel is approximately 13.5 mcg/day over a period of 8 years. The T-shaped plastic frame is 32mm by 32 mm.

Liletta should be removed at the end of the 8-year wearing time when used as a contraceptive and for 5 years when used for heavy periods and as a contraceptive. It can be replaced at the time of removal with a new device if continued contraceptive protection is wanted.

If pregnancy is not desired, Liletta can be removed at any time; however, another contraception method should be started at least 7 days before removal of the device. There is a risk of pregnancy if there has been intercourse in the week prior to removal without the use of a backup contraceptive method. 

An IUD can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about this risk.

You should not use Liletta if you are allergic to levonorgestrel, or other materials in this device. For a full list of ingredients, click here Liletta ingredients.

You should not use Liletta if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;

• an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);

• endometriosis or a serious pelvic infection following a pregnancy or abortion in the past 3 months;

• pelvic inflammatory disease (PID), unless you had a normal pregnancy after the infection was treated and cleared;

• uterine fibroid tumors or conditions that affect the shape of the uterus;

• past or present cancer of the breast, cervix, or uterus;

• liver disease or liver tumor (benign or malignant);

• a condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;

• if you have another intrauterine device (IUD) in place;

• if you had an abortion or miscarriage in the past 6 weeks; or

• if you gave birth to a baby in the past 6 weeks.

Tell your doctor if you have ever had:

• high blood pressure, heart problems, a heart attack, or a stroke;

• bleeding problems;

• migraine headaches; or

• a vaginal infection, pelvic infection, or sexually transmitted disease.

Pregnancy

Do not use during pregnancy. If left in place during pregnancy, Liletta could cause severe infection, miscarriage, premature birth, or death of the mother. The hormone Liletta may also cause unwanted effects in a female newborn.

Tell your doctor right away if you become pregnant. If you continue the pregnancy, watch for signs such as fever, chills, cramps, vaginal bleeding, or discharge.

Breastfeeding

Tell your doctor if you are breastfeeding. You may use Liletta when breastfeeding as it is not likely to affect the quality or amount of breast milk; however, a small number of patients who have taken progestin-only birth control pills report a decrease in the amount of milk produced. There is also an increased risk of Liletta becoming attached or going through the wall of the uterus when breastfeeding.

Since the IUD continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

The IUD can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted diseases. Liletta will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom may help protect from these diseases.

Call your doctor if your sex partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Common Liletta side effects may include:

• pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;

• vaginal swelling, itching or infection;

• temporary pain, bleeding, or dizziness during insertion of the IUD;

• ovarian cysts (pelvic pain that disappears within 3 months);

• stomach pain, nausea, vomiting, bloating;

• headache, migraine, depression, mood changes;

• back pain, breast tenderness or pain;

• weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or

• puffiness in your face, hands, ankles, or feet.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Serious Liletta side effects may include:

Call your doctor at once if you have:

• severe cramps or pelvic pain, pain during sexual intercourse;

• extreme dizziness or light-headed feeling;

• severe migraine headache;

• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;

• pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;

• jaundice (yellowing of the skin or eyes); or

• sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.