• Summary
• Credits

1. The Long Road of Contraceptive Development
2. Vaginal Rings
3. Transdermal Contraception
4. Contraceptive Implants
5. Combined Injectables
6. Condoms
7. Fertility Awareness-Based Methods
8. Oral Contraceptives
9. Intrauterine Devices
• A Progestin-Releasing IUS
• Frameless IUDs
10. Transcervical Female Sterilization
11. Male Hormonal Contraception
12. Bibliography
13. Web Supplements

• Clinical trials assess effectiveness and safety of new contraceptives
• New low-dose DMPA formulation
• More long-term choices for men

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Intrauterine Devices

New Intrauterine Devices Description: Progestin-releasing IUDs and IUDs without the conventional T-shaped frame. Stage of development: On the market. Effectiveness: 0.1 to 2.5 pregnancies per 100 women in the first year of use as typically used. How they work: Stimulate a sterile inflammatory response in the uterine cavity that is toxic to sperm. Progestin-releasing IUDs additionally thicken cervical mucus and suppress endometrial growth. What’s new? Progestin-releasing IUDs cause significantly less bleeding than conventional copper IUDs. They can also be used to treat heavy or excessive menstrual flow. New shapes in IUDs may reduce expulsion, pain, and bleeding.

New IUDs now on the market make insertion and removal easier and reduce expulsion, pain, and bleeding. These advances could lead to greater acceptance and use of the IUD (53, 268). New IUDs include the intrauterine system (IUS)—a type of IUD that gradually releases a progestin, which makes menstruation lighter and less painful (11)—and the frameless IUD GyneFix®, which is anchored into the uterine wall.

The levonorgestrel-releasing intrauterine system—marketed under the name Mirena (or LevoNova^® in Scandinavia) —first entered the market in Finland in 1990. It has been approved for use in more than 100 other countries over the last 15 years; the US FDA approved Mirena in 2000 (188). In 2004 the developers—the Population Council and the pharmaceutical company Leiras Oy (now Schering Oy)—established the International Contraceptive Access Foundation, which will provide public-sector organizations with the method free or at low cost in order to increase access to contraception for women in developing countries (189).

The levonorgestrel IUS initially delivers 20 µg of levonorgestrel per day. The US FDA has approved it for five years of use (223). It is significantly more effective than copper IUDs with 250 mm² of copper or less, such as the Nova-T IUD, but no more effective than IUDs with greater than 250 mm² of copper (82). The levonorgestrel IUS is also about as effective as female sterilization but—unlike sterilization—is easily reversible (223). Studies show that 0.1 to 0.2 women per 100 (1 to 2 women per 1,000) using the levonorgestrel IUS when properly inserted become pregnant in the first year of use. After 5 years of use 0.5 to 1.1 women per 100 become pregnant (11, 99).

Side effects are similar to those of other hormonal contraceptive methods. In a randomized, comparative trial users of the levonorgestrel IUS reported significantly higher rates of acne, dizziness, headaches, breast tenderness, nausea and vomiting, weight gain, and ovarian cysts (223).

In the first three months of use, the levonorgestrel IUS also causes bleeding disturbances, including breakthrough bleeding and spotting. Over time, the levonorgestrel IUS causes less bleeding than copper-bearing IUDs (183, 223, 240). Heavy or prolonged bleeding is significantly less common, and amenorrhea is significantly more common among levonorgestrel IUS users than among copper-bearing IUD users (11, 244). Between 20% and 50% of users have amenorrhea by one year (27, 104, 147). Women can also use the levonorgestrel IUS to treat heavy, prolonged bleeding or painful menstrual cramps and it may be a useful alternative to hysterectomy for some women (110).

The Belgian research organization Contrel is developing a T-shaped levonogestrel-releasing IUS, called Femilis^TM, with a small version for women who have never been pregnant (and so have smaller uteruses), called Femilis Slim. These aim to simplify insertion procedures with a “push-in technique” that does not require a plunger, as with Mirena. Femilis and Femilis Slim could be inserted by trained health care providers who do not often insert IUDs (266).

The frameless IUD—made without the plastic T-shaped frame common to most other types of IUDs—consists of several copper cylinders tied together on a string. It is anchored one centimeter deep into the fundus (top) of the uterus. This design is intended to cause less pain and bleeding than framed devices (154).

GyneFix, the newest frameless IUD, was introduced in Europe in the early 1990s, following 15 years of research to improve ease of insertion and attachment to the uterine wall (64, 264). It is also available in China and through Marie Stopes International programs in Latin America, Asia, and Africa. Its developer plans to apply for US FDA approval (263).

Small, non-comparative studies demonstrate promising results for GyneFix in minimizing menstrual blood loss and discontinuation (12, 264). Randomized controlled trials involving GyneFix have not yet provided clear support for the benefits expected, however (174). Expulsion rates have been higher than found in early clinical trials (64,154).

The frameless IUD requires an entirely different insertion technique than the framed IUD, and the level of skill required to insert them is high (154, 232, 262). Providers face difficulty with insertion even with the use of a new inserter mechanism, introduced by the developer to simplify insertion (42). The frameless IUD is less likely to be expelled when inserted by an experienced provider (262).

Another frameless IUD in development, FibroPlant-LNG, releases the progestin levonorgestrel. Based on the design of the GyneFix IUD, it too is anchored into the fundus of the uterus. FibroPlant-LNG delivers 14 µg of levonorgestrel daily and prevents pregnancy for at least three years (268).

Initial studies suggest that FibroPlant-LNG would be highly acceptable and may reduce bleeding (12, 267). For example, a pilot study of 109 women approaching menopause found that few women experienced hormonal side effects, such as irregular bleeding and spotting, even during the first three months after insertion—factors that contributed to a 98% continuation rate after the first year of use among women in the study (265, 267, 268).

Disclaimer: The information provided on this web site is not official U.S. Government information and does not represent the views or positions of the U.S. Agency for International Development or the U.S. Government.