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

Abstract

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 interim results of the first two years of use. A total of 400 women volunteers were enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minimum of 18 and a maximum of 44 years. At the cut-off date, 259 women had passed 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 and 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continuation 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 unexpected serious adverse events were encountered.