Two years of intrauterine contraception with levonorgestrel and with copper: A randomized comparison of the TCu 380Ag and levonorgestrel 20 mcg/day device

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).

Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A

“…The 7-year rates of IUD removals for pain were similar for the two devices; other studies had inconsistent findings for removal rates for pain among users of LNG and copper IUDs [5], [6], [7], [17], [24], [26], [27]. In this WHO study and the European studies of the LNG-IUD, the removal rate for hormonal reasons was higher than that of the comparator copper device [14], [17].…”

“…Development of progestogen-medicated IUDs started in the 1970s and resulted inter alia in drug regulatory approval in Finland in 1990 of an IUD with a 52-mg LNG load initially releasing 20 microg daily (Levonova®) with a 5-year effective lifespan [Wahlbom A, Bayer AB, Sweden, Personal communication 2014]. The trials preceding approval in Finland studied LNG devices loaded with 46 and 60 mg of the hormone, both releasing 20-microg LNG per day [5], [6], [7]. The US FDA approved the 5-year 52-mg LNG-medicated IUD (Mirena®) in 2000.…”

Twenty-Four–Month Continuation of Reversible Contraception

“…While the LNG-IUS is a more popular choice than the copper IUD among our participants, the 24-month continuation rates were not significantly different. The 24-month continuation rates of the LNG-IUS and earlier forms of the copper IUD (Nova T and copper-T) in previous studies ranged from 57–66% for the LNG-IUS and 68–72% for the copper IUD (15–18). These rates are slightly lower than those observed among our study population at 24 months.…”

“…These rates are slightly lower than those observed among our study population at 24 months. Several of these studies randomized participants to either IUD, while our study population was allowed to choose their desired method (15–17). Randomization may adversely affect continuation rates compared to individual choice.…”

A Risk-Benefit Assessment of the Levonorgestrel-Releasing Intrauterine System

“…Continuation rates were 25 and 29% at 5 years for the LNG-IUS and Ortho Gyne-T® 380 Slimline, respectively. [33][34][35][36] Fundal positioning of the LNG-IUS is particularly important in order to ensure uniform exposure of the endometrium to the progestogen, prevent expulsion and maximise efficacy. Training in the proper insertion technique is therefore emphasised.…”