Two-year clinical experience with Nova-T 380, a novel copper-silver IUD

In 1992, an open single-group phase III clinical trial was started at three centers to investigate the clinical performance of the high copper surface area Nova-T 380, a modification of Nova-T. This report presents the interi m results of the first two years of use. A total of 400 women volunteers we re enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minim um of 18 and a maximum of 44 years. At the cut-off date, 259 women had pass ed the 24-month visit. Gross cumulative life-table rates at the end of the first and second years, respectively, calculated by the Kaplan-Meier method , were as follows: pregnancy 0.5 and 1.6, expulsion 1.6 and 2.8, bleeding 4 .7 and 8.7, pain 1.3 and 2.3, removal for other medical reasons 1.7 and 3.9 , planning pregnancy 1.1 and 6.0, removal for other personal reasons 0.5 an d 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continua tion rates were 89.0 and 75.5 at 12 and 24 months, respectively. The first two-year performance of the Nova-T 380 was good. Bleeding problems were in the same range as with devices with smaller copper surface areas. No unexpe cted serious adverse events were encountered.