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

Abstract

ObjectivesTo compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) levonorgestrel IUD (LNG-IUD) or the copper T 380 A (TCu380A) intrauterine device.Study designThis was an open-label 7-year randomized controlled trial in 20 centres, 11 of which in China. Data on 1884 women with interval insertion of the LNG-IUD and 1871 of the TCu380A were analysed using life tables with 30-day intervals and Cox proportional hazards models.ResultsThe cumulative 7-year pregnancy rate of the LNG-IUD was 0.5 (standard error 0.2) per 100, significantly lower than 2.5 (0.4) per 100 of the TCu380A, cumulative method discontinuation rates at 7 years were 70.6 (1.2) and 40.8 (1.3) per 100, respectively. Dominant reasons for discontinuing the LNG-IUD were amenorrhea (26.1 [1.3] per 100) and reduced bleeding (12.5 [1.1] per 100), particularly in Chinese women and, for the TCu380A, increased bleeding (9.9 [0.9] per 100), especially among non-Chinese women. Removal rates for pain were similar for the two intrauterine devices (IUDs). Cumulative rates of removal for symptoms compatible with hormonal side effects were 5.7 (0.7) and 0.4 (0.2) per 100 for the LNG-IUD and TCu380A, respectively, and cumulative losses to follow-up at 7 years were 26.0 (1.4) and 36.9 (1.3) per 100, respectively.ConclusionThe LNG-IUD and the TCu380A have very high contraceptive efficacy, with the LNG-IUD significantly higher than the TCu380A. Overall rates of IUD removals were higher among LNG-IUD users than TCu380A users. Removals for amenorrhea appeared culturally associated.ImplicationsThe 52-mg LNG-IUD and the TCu380A have very high contraceptive efficacy through 7 years. As an IUD, the unique side effects of the LNG-IUD are reduced bleeding, amenorrhea and symptoms compatible with hormonal contraceptives.

One-year continuation of copper or levonorgestrel intrauterine devices initiated at the time of emergency contraception

“…Research on continuation demonstrates that most women discontinue device use well before FDA expiration [4]. One-year continuation rates for standard intrauterine device (IUD) initiation in previously published studies range from 82% to 88% for LNG 52 mg IUD and 84% to 90.5% for Cu T380A IUD [5–8]. Scant published data exist on 1-year continuation rates when an IUD is initiated at the time of EC.…”

Long-Acting Reversible Contraception

“…50,51 A recent multicountry study showed a 7-year cumulative pregnancy rate of less than 1 pregnancy per 100 woman-years among women who used a 52-mg LNG-IUD. 12 In a U.S. study, 1 pregnancy was reported among 263 women who used a 52-mg LNG-IUD during the sixth year of use (pregnancy rate, 0.51 per 100 womanyears), and no pregnancies were reported among 123 implant users during the fourth year of use or among 34 implant users during the fifth year of use. 50 A multicountry study showed no pregnancies among 204 implant users during the fourth and fifth years of use.…”

“…9 Less than 1% of women become pregnant during the first year of IUD use, with pregnancy rates with the LNG-IUD (0.1 to 0.2%) generally reported as lower than the rates with the coppercontaining IUD (0.5 to 0.8%). [10][11][12] ParaGard is approved by the FDA for 10 years of use, Mirena and Kyleena for 5 years, and Skyla for 3 years. As of November 2016, Liletta is approved for 3 years of use, but data are being collected to assess 5-year use.…”

Oral Contraceptives after Bariatric Surgery

“…The hormonal IUDs are highly efficacious, with less pregnancy rates than the copper IUDs [69]. However, discontinuation of treatment has been reported due to dysmenorrhea, pain, device expulsion, pelvic inflammatory disease, and infection [70,71]. …”