APPLICATION FOR INCLUSION OF LEVONORGESTREL - RELEASING INTRAUTERINE SYSTEM FOR CONTRACEPTION IN THE 14 th WHO MODEL LIST OF ESSENTIAL MEDICINES

Background Contraception is a truly valuable medical advance for women and society. There are different contraceptive methods, and the women's choice and acceptance of them is likely to be affected by the efficacy, acceptability, tolerability and availability of alternatives and the desire not to conceive. In the 1970s a new approach to the delivery of hormonal contraception was researched and developed. It was suggested that the addition of a progestogen to a non-medicated contraceptive device improved its contraceptive action. Indeed, local levonorgestrel has a strong antiproliferative action on the endometrium. The endometrium becomes unresponsive to ovarian estrogens, although ovulation is usually not suppressed. This process is associated with progressive reduction of menstrual blood loss and menstrual duration. The menstrual pattern and fertility return to normal soon after the levonorgestrel-releasing IUS is removed. Among IUDs, levonorgestrel-releasing intrauterine system (LNG-IUS) has been used for reversible contraception. It has a T shaped plastic frame 32 mm long with a reservoir on the vertical stem of the IUS containing 52 mg of levonorgestrel mixed with polydimethylsiloxane. This allows a steady, local release of 20 microg levonorgestrel per day during the first year and 11 microg per day after 5 years with an average of 14 microg per day over 5 years. The LNG-releasing IUS should be installed during the first seven days of the cycle. Post-partum insertion can be done six weeks after normal delivery and twelve weeks after caesarean section. Insertion of the LNG-20 IUS may require local anaesthesia and dilatation of the cervical canal in nulliparous or perimenopausal woman. The net ingredient cost of the LNG-20 IUS is more expensive than copper bearing IUDs, however it offers non-contraceptive benefits particularly in women with heavy periods and may offer an alternative to hysterectomy. About 145 million women are using Intrauterine Device (IUD) worldwide, which represents 14% of women in reproductive age. Generally, IUDs are the second most popular contraceptive method after sterilization. LNG-releasing IUS is available in 47 countries. LNG-IUS is registered in most European countries and the USA, as well as in increasing number of developing countries. Estimate of total