HEALTH DURING PROLONGED USE OF LEVONORGESTREL 20 MU-G D AND THE COPPER TCU 380AG INTRAUTERINE CONTRACEPTIVE DEVICES - A MULTICENTER STUDY/

Objectives: To measure and compare the incidence of adverse events dur ing use of two medicated intrauterine devices (IUDs). Design: A multic enter prospective 7-year randomized study. Setting: Family planning cl inics, primarily in developing countries. Subjects: Women age 18 to 38 years at admission, desiring contraception and without contraindicati ons to IUDs. Main Outcome Measures: Incidence of complaints, condition s, and rates of specific termination for each IUD. Methods: Subjects r ecorded menstrual events, and clinical staff registered all complaints and conditions found on examination at four first-year clinic visits and at semiannual visits thereafter. Difference in rates were analyzed by chi 2 statistics. Results: Annual pregnancy rates for each IUD ave raged 0.2/100 women whereas upper genital tract infection occurred at rates of 0.6 to 0.7 per 100 years of use. The levonorgestrel-releasing IUD significantly decreased bleeding and spotting days in comparison with historical data for noncontraceptors and with the copper-medicate d IUD. Dysmenorrhea, vaginitis, and myoma in women with the levonorges trel IUD were markedly decreased in comparison with the experience of copper IUD users. Significantly higher rates of amenorrhea, delayed ov arian follicular atresia, skin and hair conditions, and headache were observed with the steroid IUD than with the copper-releasing IUD. Rate s of reported adverse effects for either IUD were highest in the first 2 years of use and among women under age 25. Conclusions: Long-term u se of copper or levonorgestrel IUDs is characterized by very low rates of pregnancy and by a low and declining annual incidence of side effe cts, including pelvic infection and borderline anemia. The levonorgest rel-releasing IUD reduced the incidence of bleeding and, in the long t erm, of myoma and myoma-related surgery in comparison with the copper T IUD. Both IUDs proved highly acceptable and had few unanticipated si de effects.