The TCu 380A and FlexiGard IUDs were compared in a randomized multicenter trial including 28 institutes in 13 countries. There were 53 insertion failures with the FlexiGard and one with the TCu 380A. There were 2184 successful insertions of the TCu380A and 2102 of the FlexiGard device. The three-year pregnancy rates for the TCu 380A and FlexiGard were similar (1.6 and 1.9 per 100 women, respectively) but the FlexiGard three-year expulsion rate (7.4 per 100 women) was significantly higher than that of the TCu 380A (4.4 per 100 women). The insertion technique for the FlexiGard needs to be improved in order to lower the expulsion rate.