CONTRACEPTIVE EFFICACY OF THE COPPER-T-380A AND COPPER-T-200 INTRAUTERINE-DEVICES - RESULTS FROM A COMPARATIVE CLINICAL-TRIAL IN 6 DEVELOPING-COUNTRIES

The clinical performance of the Copper T 380A (TCu 380A) and the Coppe r T 200 (TCu 200) intrauterine devices (IUDs) was evaluated for 12 mon ths in a group of women who had one of the two IUDs inserted. Results are from a multicenter randomized clinical trial at one site in each o f six developing countries. The pregnancy rate with the TCu 380A IUD w as significantly lower than the pregnancy rate with the TCu 200 IUD at 12 months (0.5 and 2.6 per 100 women, respectively, p<0.01). No stati stically significant differences between the two study IUDs were found with regards to expulsion or removals due to bleeding/pain, personal, medical, or planned pregnancy. The TCu 380A IUD did not have a dispro portionately higher incidence of side effects such as intermenstrual b leeding or pain, inflammations or infections, or insertion-related eve nts compared to the TCu 200 IUD. TCu 380A IUD users, however, were sig nificantly more likely to report increased dysmenorrhea than were TCu 200 IUD users. The performance of the TCu 380A IUD in preventing pregn ancy during this trial indicates that this IUD may be a better option than the TCu 200 IUD for women wishing to practice effective, long-ter m, reversible birth control without having to resort to hormonal metho ds.