Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Jun;93(6):498-506.
doi: 10.1016/j.contraception.2016.02.024. Epub 2016 Feb 23.

Safety and Efficacy in Parous Women of a 52-mg Levonorgestrel-Medicated Intrauterine Device: A 7-year Randomized Comparative Study With the TCu380A

Free PMC article
Randomized Controlled Trial

Safety and Efficacy in Parous Women of a 52-mg Levonorgestrel-Medicated Intrauterine Device: A 7-year Randomized Comparative Study With the TCu380A

Patrick Rowe et al. Contraception. .
Free PMC article

Erratum in


Objectives: 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).

Study design: 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.

Results: 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.

Conclusion: 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.

Implications: 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.

Keywords: Levonorgestrel IUD; Mirena®; Paragard®; Randomized trial; Seven years; TCu380A.


Fig. 1
Fig. 1
Number of women eligible, randomized and followed up in the trial of the 52-mg LNG 20 micro-releasing IUD and the TCu380A IUD.
Fig. 2
Fig. 2
Cumulative rates (per 100) of selected reasons for IUD removal by device in all Chinese and non-Chinese centres.

Similar articles

See all similar articles

Cited by 12 articles

See all "Cited by" articles


    1. UNDP/UNFPA/WHO/World Bank, Special Programme of Research, Development, Research Training in Human Reproduction, Task Force on the Safety and Efficacy of Fertility Regulating Methods The TCu 380 A, TCu 220C, multiload 250 and Nova T IUDs at 3, 5 and 7 years of use - results from three randomized multicenter trials. Contraception. 1990;42:141–158. - PubMed
    1. United Nations Development Programme/United Nations Population Fund/World Health Organization/World Bank, Special Programme of Research, Development and Research Training in Human Reproduction Long-term reversible contraception: twelve years of experience with the TCu380A and TCu220C. Contraception. 1997;56:341–352. - PubMed
    1. Sivin I., Greenslade F., Schmidt F., Waldman S.N. The Population Council; New York: 1992. The copper T 380 intrauterine device: a summary of scientific data.
    1. O'Brien P.A., Kulier R., Helmerhorst F.M., Usher-Patel M., d'Arcangues C. Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials. Contraception. 2008;77:318–327. - PubMed
    1. Luukkainen T., Allonen H., Hankkamaa M., Holma P., Pyörälä T., Terho J. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-months report of a European multicentre study. Contraception. 1987;36:169–179. - PubMed

Publication types

MeSH terms