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

doi:10.1016/j.contraception.2016.02.024

Contraception

Volume 93, Issue 6, June 2016, Pages 498-506

https://doi.org/10.1016/j.contraception.2016.02.024 Get rights and content

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Abstract

Objectives

To 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 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®

TCu380A

Paragard®

Randomized trial

Seven years

Cited by (0)

^☆: The authors declare no conflicts of interest.

^☆☆: The authors alone are responsible for the views expressed in this article, and they do not necessarily represent the decisions, policy or views of the World Health Organization.

¹

The IUD Research Group of the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Centres and Principal Investigators participating in the conduct of trial:

Brazil, Juiz de Flora, Dr. A Andrade;

Chile, Santiago, Hospital E. Barros Lucos-Trudeau, Dr. P Lavin;

Chile, Temuco, Universidad de la Frontera, Dr. P Valdes;

China, Wuhan, Dr. Wu Xi Rui;

China, Tianjin, Dr. Cao Xiao Ming;

China, Shanghai Xin Hua, Dr. Liu Qing-Xi;

China, Shanghai Ren Ji, Dr. Wu Yu-Feng;

China, Shanghai IPP, Dr. Feng Zuan Chong;

China, Shanghai IPMCH, Dr. Zhuang Liu Qi;

China, Nanjing, Dr. Qian Shao-Zhen;

China, Chengdu, Dr. Luo She Yuan;

China, Beijing, Peking Union Medical College, Dr. Wu Yu-Ming;

China Beijing NRIFP, Dr. Wu Shang Chun;

China, Beijing O&G, Dr. Fan Hui Min;

Hungary, Szeged, Dr. G Bartfai;

Slovenia, Ljubljana, Dr. M Puksic;

Mongolia, Ulaanbaatar State Research Centre on MCH, Dr. R Erdenetungalag;

The Philippines, Manila, Dr. R Ramos;

Thailand, Bangkok, Chulalongkorn University Hospital, Dr. Damrong Reinprayoon;

Tunis, Centre d'Etude et de Recherce en RH, Dr. R Hamszaoui.

Study coordinator: Dr. P Rowe.

Data Management: Dr. P Rowe, Ms. S. Boccard, Dr. A Peregoudov, Ms. Sihem Landoulsi.

Data analysis: Dr. A Peregoudov, Dr. G Piaggio, Dr. T Farley, Dr. P Rowe, Dr. O Meirik.

Writing group: Dr. O Meirik, Dr. P Rowe, Dr. G Piaggio, Dr. T Farley, Dr. A Peregoudov.

Address correspondence to: Dr. O Meirik, Jose Victorino Lastarria 29 Depto 1, 8320164 Santiago Centro, Chile. E-mail: [email protected].