CLINICAL-PERFORMANCE OF THE TCU 380A AND LIPPES LOOP IUDS IN 3 DEVELOPING-COUNTRIES

The clinical performance of the Copper T 380A (TCu 380A) and the Lippe s Loop intrauterine devices (IUDs) were evaluated for 12 months in a g roup of 710 women who had one of the two IUDs inserted. Results are fr om a randomized clinical trial conducted at three collaborating resear ch sites located in three developing countries. The gross cumulative l ife-table pregnancy rate of the TCu 380A IUD was found to be lower tha n that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per 100 women, respectively). Although this difference was not statistically signifi cant (p = 0.25), it is similar to findings from other studies. The 12- month cumulative removal rate due to personal reasons was significantl y different (1.4 and 0.0, respectively, p = 0.05). Statistically signi ficant differences between the two study IUDs were not found with rega rd to IUD expulsion or IUD removal due to bleeding/pain, medical reaso ns, planned pregnancy or investigator's choice. A statistically signif icant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study per iod, compared to Lippes Loop IUD users (18.8%).