title: Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A.
abstract: To compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) intrauterine device (LNG-IUD) or the copper T 380 A IUD (TCu380A).
  
  
  
  This 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.
  
  
  
  The 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.
  
  
  
  The 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.
  
  
  
  The 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.
authors.affiliation: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
authors.forename: Patrick
authors.initials: P
authors.lastname: Rowe
authors.affiliation: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
authors.forename: Tim
authors.initials: T
authors.lastname: Farley
authors.affiliation: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Peregoudov
authors.affiliation: Medical Statistics Department, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Gilda
authors.initials: G
authors.lastname: Piaggio
authors.affiliation: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
authors.forename: Simone
authors.initials: S
authors.lastname: Boccard
authors.affiliation: Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
authors.forename: Sihem
authors.initials: S
authors.lastname: Landoulsi
authors.affiliation: Instituto Chileno de Medicina Reproductiva (ICMER), Santiago, Chile. Electronic address: meiriko@icmer.org.
authors.forename: Olav
authors.initials: O
authors.lastname: Meirik
mesh_terms: D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced; D003271:Contraceptive Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D020878:Device Removal / Q000706:statistics & numerical data*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects; D016912:Levonorgestrel / Q000008:administration & dosage* / Q000009:adverse effects; D061214:Patient Safety; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D016016:Proportional Hazards Models; D013997:Time Factors
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
keywords: Levonorgestrel IUD; Mirena®; Paragard®; Randomized trial; Seven years; TCu380A