Acceptability of the levonorgestrel-releasing intrauterine system after discontinuation of previous contraception: results of a French clinical study in women aged 35 to 45 years

This open, noncomparative study evaluated the rate of premature removals of the levonorgestrel-releasing intrauterine system (LNG-IUS) Mirena because of adverse events. To take part in the study, women had to be aged between 35 years and 45 years, and had to change their contraception for poor compliance, poor tolerance, or unfavorable change in the benefit/risk ratio of their previous contraception (oral contraceptives or copper- or progestin-releasing intrauterine device). One removal of Mirena for a wish for pregnancy was excluded from analyses, so that there were 23 removals among 203 women included. The survival ratio was 88.7%, which corresponds to a 1-year rate of premature removals of 11.3%. No statistically significant difference was found between women switched from IUD and women switched from oral contraception regarding the continuation rate (p 0.640, log-rank test) and the discontinuation rate (p = 0.430, chi(2) test). The main reasons for premature removal were bleeding problems (11 subjects including 2 amenorrhea, 5.4%), pain (5 subjects, 2.5%), and acne (2 subjects, 1%). Two premature discontinuations occurred after accidental removal. The number of bleeding or spotting days significantly decreased from baseline (p < 0.001), and gynecological symptoms were alleviated. Hematocrit, hemoglobin levels, and serum ferritin increased significantly. No pregnancies occurred. Acne and irregular bleedings were the most frequent adverse events. The results show the excellent acceptability as well as the favorable efficacy/safety ratio of the LNG-IUS Mirena in older reproductive age women whatever the primary method of contraception. (C) 2002 Elsevier Science Inc. All rights reserved.