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  • Title: Two years of intrauterine contraception with levonorgestrel and with copper: a randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day devices.
    Author: Sivin I, Stern J, Diaz J, Diaz MM, Faundes A, el Mahgoub S, Diaz S, Pavez M, Coutinho E, Mattos CE.
    Journal: Contraception; 1987 Mar; 35(3):245-55. PubMed ID: 3111785.
    Abstract:
    IUDs releasing 20 mcg/day of levonorgestrel (LNg20) were in randomized trial together with the Copper T, model TCu 380Ag, in seven centers involving 2244 women. Two-year (25 months) gross cumulative pregnancy rates were 0.2 +/- 0.2 and 0.9 +/- 0.3 for the levonorgestrel and copper releasing devices, respectively (P greater than 0.05). There were no ectopic pregnancies in more than 1600 woman-years of use of each device. Removal rates for bleeding and/or pain or for medical reasons other than menstrual problems did not differ significantly between devices. Oligomenorrhea or amenorrhea prompted 10.7 per hundred (gross rate, 8.4 net rate) women using the LNg 20 IUD to request removal in the two-year period, significantly above the 0.2 per hundred rate among women with the Copper IUD (P less than 0.001). At the end of two years an estimated 59.4 per 100 women were continuing use of the LNg 20 IUD, and 67.5 per 100 (P less than 0.001) with the TCu 380Ag. This difference is almost wholly ascribable to a marked reduction in bleeding episodes and days among women using the LNg 20 device with concomitant removal of device. Hemoglobin rose an average of 0.5 g/dl (P less than 0.001) for this group whereas women using the TCu 380Ag experienced a decline of 0.2 g/dl compared with baseline values (P less than 0.001). An IUD releasing 20 mcg/day of levonorgestrel (LNg20) was compared with a Copper T IUD (TCu 380 Ag) in a randomized trail involving 2244 women 7 centers in the US, Brazil, Egypt, Chile, Singapore, and the Dominican Republic. The cumulative gross pregnancy rate at 2 years was 0.2 for the LNg 20 device and 0.9 for the TCu 380 Ag IUD. There were no ectopic pregnancies in more than 1600 woman-years of use of each device. The removal rates due to oligomenorrhea or amenorrhea were 10.7/100 among LNg 20 acceptors compared with only 0.2/100 among TCu 380 Ag acceptors in the 2-year study peroid. Removal rates for pain and/or bleeding did not differ significantly between devices. Hemoglobin rose an average of 0.5 g/dl in the LNg 20 group and declined an average of 0.2 g/dl in the TCu 380 Ag group. At the end of 2 years, the continuation rates were 59.4/100 among LNg 20 acceptors and 67.5/100 among TCu 380 Ag acceptors. This difference is ascribable to the scanty and infrequent bleeding patterns associated with the former device. It is concluded that both these IUDs provide highly effective intrauterine protection.
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