Abstract
OBJECTIVE: Levonorgestrel-releasing intrauterine system (LNG-IUS) is increasingly used for contraception, treatment of heavy menstrual bleeding and endometrial protection during hormone replacement therapy. LNG-IUS has been available in most European countries since early / mid 1990's. Due to its high acceptability and efficacy, many women opt for consecutive use of the LNG-IUS. However, published data on the repeated use of the LNG-IUS is limited. DESIGN: Prospective single group multicenter study performed in four European countries. MATERIALS AND METHODS: Fertile aged women who had used their 1st LNG-IUS between 4 years and 3-9 months and who opted for an immediate insertion of a 2nd IUS. The main outcome measure was the bleeding profile of the 2nd LNG-IUS during its first year of use. Additionally, the acceptability, efficacy and safety of the LNG-IUS was assessed. Bleeding data were recorded on a daily basis and analyzed per 90-day reference period (RF). The bleeding data obtained during the last 90 days of the 1st IUS (baseline) and the first 4 RFs after insertion of the second Mirena were analyzed descriptively. RESULTS: Median age of the 204 subjects that entered the study was 39 years (range 23-45), and median number of births was 2 (range 0-4). 191 subjects (93.6%) completed the study. The median number of bleeding/spotting days at baseline was 7 (25th to 75th percentiles 0-15). Due to bleeding associated with the insertion procedure, this increased to 8 days (range 4-18) during the 1st RF, thereafter decreasing to 4 days (range 0-10/11) during the 2nd - 4th RF. One expulsion and no pregnancies, pelvic inflammatory diseases or perforations occurred. A total of 12 subjects (5.9%) prematurely discontinued the study: 5 due to an adverse event and 7 due to other reasons (incl. loss to follow-up). CONCLUSIONS: This study confirms the favourable bleeding profile, high acceptability, efficacy and safety of repeat use of the LNG-IUS.
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