In the U.S.—

• Contraceptive, intrauterine-local

A progesterone intrauterine device (proe-JES-ter-one IN-tra-YOU-ta-rin de-VICE) (also called an IUD) is inserted by a health care professional into a woman's uterus as a contraceptive (birth control method).

The progesterone IUD works by causing changes in the uterus that help to prevent pregnancy. The fertilization of the woman's egg with her partner's sperm is less likely with an IUD in place, but it can occur. Even so, the IUD makes it harder for the fertilized egg to become attached to the uterus walls, making it hard to become pregnant. The hormone, progesterone, released from the IUD is believed to improve the effects of the device. After the IUD is removed, most women trying to become pregnant can become pregnant.

Studies have shown that pregnancy can occur in up to 2 of each 100 women using a progesterone IUD during the first year of use . Other birth control methods such as not having intercourse, taking birth control pills (the Pill), or having surgery to become sterile are as effective or more effective. Methods that do not work as well include using condoms, diaphragms, vaginal sponges, or spermicides. Discuss with your health care professional what your options are for birth control and the risks and benefits of each method.

IUDs do not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence (not having intercourse) is recommended for protection from these diseases.

Your lifestyle will determine how safe and reliable the progesterone IUD will be for you. Problems that may occur with use of an IUD are far less likely to occur in women who have a long-term relationship with one sexual partner. Also, it is important that your sexual partner not have any other sexual partners. If you or your partner has more than one sexual partner it increases your chance of getting an infection in the vagina. If an infection is present in the vagina or uterus when the IUD is in the uterus it may make an infection more serious. If your lifestyle changes while you are using an IUD or you get or are exposed to a sexually transmitted disease, call your health care professional.

Progesterone IUDs are available only from your doctor or other authorized health care professional in the following form:

Intrauterine
• Progesterone Intrauterine Device (U.S.)

In deciding whether to use a progesterone IUD as a method of birth control, you need to consider the risks of using it as well as the good it can do. This is a decision you, your sexual partner, and your health care professional will make. For progesterone IUDs, the following should be considered:

Pregnancy—IUD use is not recommended during pregnancy or if you plan to become pregnant in the near future. It is also not recommended in women who have had a pregnancy develop outside of the uterus (ectopic pregnancy).

There is a rare chance that a woman can become pregnant with the IUD in the uterus. If this happens, it is recommended that the IUD be removed or that the pregnancy be ended within the first 3 months. If the pregnancy continues, removing the IUD decreases the chance of a problem developing. However, whether the IUD is removed or not, some problems can occur. Some of these problems include miscarriage, premature labor and delivery, infection, and, very rarely, death of the mother.

Your health care professional will help you decide on the proper time to begin using an IUD after delivering a baby. Sometimes problems can occur if you start using the IUD too soon after delivery. These problems include having the IUD move out of place or having it press into the walls of the uterus or the cervix (opening to the uterus). These problems may harm the cervix or uterus, causing pain or unusual uterine bleeding. Call your health care professional immediately if you have any problems.

Breast-feeding—The progesterone IUD has not been shown to cause problems in nursing babies and its use is recommended for those women needing contraception while breast-feeding.

Teenagers who have not had children usually have more side effects than teenagers or adults who have had children. In teenagers who have not had children, the IUD may move out of place. This may harm the uterus or cervix. Abdominal pain and increased menstrual bleeding also are more common in teenagers than in women who are older and have had children.

• Abnormal uterus—May decrease the IUD's ability to prevent pregnancy or may increase the chance of problems, such as the IUD moving out of the uterus or pressing through the cervix or uterus

• Acquired immunodeficiency syndrome (AIDS), autoimmune diseases, treatable cancer, suspected or known cancer of the uterus or cervix, or any other condition that may decrease the ability of the body to fight infection—These conditions may increase the chance of a vaginal infection occurring with the use of an IUD

• Blood disorders or
• Uterine bleeding problems, especially heavy bleeding during periods or bleeding between periods—At the time of insertion, use of a progesterone IUD can make uterine bleeding worse, although this lessens with continued use. Also, heavy uterine bleeding may cause the IUD to move out of place

• Diabetes, insulin-dependent or
• Heart defect—If an infection occurs during use of an IUD, the infection may become worse and/or be harder to treat in these patients

• Ectopic pregnancy (pregnancy not in the uterus), history of—The chance of an ectopic pregnancy may be increased if contraception fails during IUD use

• Fainting (history of) or
• Slow heartbeat (history of)—The chance of problems may be increased when, or soon after, the IUD is inserted

• Infection in the vagina or uterus or
• Recent infected abortion or
• Sexually transmitted disease in the last 12 months—Use of an IUD may make an infection worse

• Surgery involving the uterus or fallopian tubes—Certain surgeries of the uterus or the fallopian tubes may increase the chance of problems if an IUD is present in the uterus. Also, if contraception fails, the chance of an ectopic pregnancy may be higher

IUDs come with patient information. You must understand this information. You should keep a copy for reference. Be sure you understand possible problems with the progesterone IUD, especially side effects, risks, and warning signs of trouble.

Spermicides such as contraceptive foams or creams are not needed to prevent pregnancy with a properly placed progesterone IUD.

It is important that you check for the IUD threads every month (if not more often) especially after each menstrual period. Feeling the IUD threads near the cervix lets you know that the progesterone IUD is still in place.

To check for the IUD threads:

• Wash your hands thoroughly.
• Squat and, using your middle finger, find the cervix high in the vagina.
• The IUD threads should hang down from the cervix.
• Do not pull on the threads.

Dosing—

Follow your health care professional's orders to schedule the proper time to remove and replace your progesterone IUD, usually at 12 months. You and your health care professional may choose to replace it sooner or begin a new method of birth control.

• For preventing pregnancy:
  • For progesterone dosage form:
    • Adults and teenagers—One device inserted into the vagina by a health care professional and replaced within 12 months of use.

It is very important to keep all medical appointments with your health care professional during the first year of IUD use. This will allow the health care professional to make sure that the device is still in place and working properly.

Check with your medical doctor if you plan to have surgery of the uterus or fallopian tubes. Your doctor may remove your IUD before the surgery or help you choose another type of treatment.

Tell your doctor immediately if you think that the IUD has moved out of place. Do not try to put the IUD back into place inside the uterus. Do not try to remove the IUD.

Although IUDs are very reliable, there is a rare chance that the IUD may fail to protect some people from becoming pregnant. Very rarely a pregnancy can occur outside of the uterus; this is called an ectopic pregnancy. It can be hard to tell if an ectopic pregnancy has occurred. Unlike a normal pregnancy in the uterus, which stops the menstrual period, some people can still have a menstrual period with an ectopic pregnancy. These women may not think they are pregnant.

Notify your doctor immediately if you feel many of the following changes that can occur with a pregnancy: Enlarged or tender breasts, lack of or unusual menstrual period, lower abdominal pain or cramping (possibly severe), sore abdomen, unusual tiredness or weakness, unusual uterine bleeding (in some cases, very heavy).

If you think you are pregnant or if you miss a period while you are using the IUD, tell your health care professional. Until your doctor is able to see you, use another birth control method, such as condoms, to prevent pregnancy just in case you are not pregnant.

Also, notify your doctor and use another birth control method, such as condoms, if:

• you have unusual uterine bleeding;
• you are exposed to or get a sexually transmitted disease (STD);
• you feel the tip of the IUD at the cervix or you or your partner feels pain during sexual intercourse;
• you cannot find the threads from the IUD or think that the thread length is different;
• you or your sexual partner's lifestyle changes and one or both of you have more than one sexual partner;
• you have unusual or severe lower abdominal pain or cramping, possibly with a fever; or
• you develop vaginal discharge or sores in the vaginal area.

You can use other products in the vagina, such as tampons or condoms, while you are using a progesterone IUD.

After you stop using this device, you may become pregnant. The contraceptive effect of a progesterone IUD is usually reversible. If you stop using an IUD and still do not want to become pregnant, you should begin using another contraceptive method immediately to prevent pregnancy.

Along with its needed effects, a progesterone IUD may cause some unwanted effects. Although not all of these side effects may occur, if any do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

• Rare
  • Abdominal pain or cramping (severe);  faintness, dizziness, or sharp pain at time of IUD insertion;  uterine bleeding (heavy or unexpected) 
  
  

Check with your health care professional immediately if any of the following side effects occur:

• More common
  • Abdominal pain or cramping on insertion (continuing);  unusual spotting or uterine bleeding between periods;  unusual uterine bleeding on insertion (continuing) 
  
  

• Rare
  • Abdominal pain, continuous (dull or aching), fever, odorous vaginal discharge, unusual tiredness or weakness, and any unusual uterine bleeding  
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.