Bleeding pattern and safety of consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS)-a multicentre prospective study

被引:30
|
作者
Gemzell-Danielsson, K. [2 ]
Inki, P. [3 ]
Boubli, L. [4 ]
O'Flynn, M.
Kunz, M. [5 ]
Heikinheimo, O. [1 ]
机构
[1] Helsinki Univ Cent Hosp, Dept Obstet & Gynaecol, Helsinki 00029, Finland
[2] Karolinska Univ Hosp, Dept Obstet & Gynaecol, Stockholm, Sweden
[3] Bayer Schering Pharma AG, Global Med AffairsWomens Hlth, Berlin, Germany
[4] Hop Nord, Paris, France
[5] Bayer Schering Pharma AG, Dept Clin Stat, Berlin, Germany
关键词
bleeding profile; insertion; contraception; heavy menstrual bleeding;
D O I
10.1093/humrep/dep426
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
The LNG-IUS has increasingly been used for contraception, treatment of menorrhagia and endometrial protection during hormone replacement therapy since mid-1990s. Thus, many women use the LNG-IUS consecutively. However, published data on the bleeding pattern regarding consecutive use of the LNG-IUS is scarce. We performed a prospective 15-month multicentre study on the bleeding profile, removal and insertion procedures and safety of the second LNG-IUS in fertile-aged women who had used their first LNG-IUS between 4 years 3 months and 4 years 9 months and who opted for the insertion of a second IUS immediately after removal of the first IUS. Bleeding data were reported descriptively starting from the last 90 days of the first IUS use and continuing for up to 1 year. Of the 234 subjects screened, 204 (87%) entered the trial. The median number of bleeding/spotting days during the last 90 days of the first LNG-IUS was 7 (25 and 75% percentiles 0 and 15). Due to bleeding associated with the insertion procedure, this increased to 8 days (4 and 18) during the first 90-day reference period, thereafter decreasing to 4 (0 and 10) days during the second to fourth reference periods. Only one expulsion and no pregnancies, pelvic inflammatory diseases or perforations occurred. A total of 12 subjects (5.9%) prematurely discontinued the study: five due to an adverse event and seven due to other reasons (inclusive of loss to follow-up). This study confirms the favourable bleeding profile and safety of consecutive use of the LNG-IUS.
引用
收藏
页码:354 / 359
页数:6
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