OBJECTIVE:To assess the relative contraceptive effectiveness, tolerability and acceptability of the levonorgestrel-releasing (20 microg per day) intrauterine system (LNG-20) compared with reversible contraceptive methods in women of reproductive age. DESIGN:A systematic review and meta-analysis of randomised controlled trials. IDENTIFICATION:Studies were identified through seven databases, and by contacting investigators and organisations working in the contraceptive field. MAIN OUTCOME MEASURES:Unplanned pregnancy and continuation of contraceptive method. RESULTS:Five of the seven randomised controlled trials which met the inclusion criteria were included in the meta-analyses; four were comparisons of the LNG-20 intrauterine system with nonhormonal intrauterine devices. LNG-20 intrauterine systems were compared with intrauterine devices divided into two categories, those > 250 mm3 (Copper T 380 Ag and Copper T 380A intrauterine devices) and those < or = 250 mm3 (Nova-T, Copper T 220C and Copper 200 intrauterine devices). Pregnancy rates for the LNG-20 intrauterine system users were significantly less likely to become pregnant compared with users of intrauterine devices < or = 250 mm3, and significantly less likely to have an ectopic pregnancy. LNG-20 intrauterine system users were more likely to experience amenorrhoea and device expulsion than women using intrauterine devices > 250 mm3. LNG-20 intrauterine system users were significantly more likely than all the intrauterine device users to discontinue because of hormonal side effects and amenorrhoea. When the LNG-20 intrauterine system was compared with Norplant-2, the LNG-20 users were significantly more likely to experience oligo-amenorrhoea, but significantly less likely to experience prolonged bleeding and spotting. CONCLUSIONS:The effectiveness of the LNG-20 intrauterine system was similar to or better than other contraceptive methods with which it was compared. Amenorrhoea was the main reason for the discontinuation of the LNG-20 intrauterine system, usually unnecessarily, since this end-organ suppression of bleeding is benign, associated with normal oestrogen levels. Women choosing this method should be informed of potential amenorrhoea when having pre-contraceptive counselling and that absent bleeding may be viewed as a positive outcome.