Safety and efficacy of intrauterine devices: Baseline characteristics of 37,186 study participants from the EURAS-LCS12 study
ESC Congress Library. Hagemann C. 05/11/18; 208250; ESC269 Disclosure(s): The study was funded by an unconditional grant from Bayer Pharma AG (Germany). An independent international Advisory Council is responsible for all scientific matters.
Christine Hagemann
Christine Hagemann
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Background: Intrauterine contraceptive methods, such as Mirena and CU-IUDs, have a high contraceptive efficacy. Jaydess is a new IUS containing Levonorgestrel, with lower initital release rates per day compared to Mirena (14 µg vs. 20 μg). Jaydess is indicated for contraception for up to 3 years use. Data from routine clinical practice comparing the contraceptive efficacy of Jaydess, Mirena and CU-IUDs is not available so far. Objective: The primary outcome of the 'European Active Surveillance Study on LCS12' (EURAS-LCS12) is contraceptive failure in users of Jaydess, Mirena or any CU-IUD. Secondary outcomes are risk of ectopic pregnancies, pelvic inflammatory disease (PID), and uterine perforation. Methods: Large, prospective, controlled, non-interventional cohort study with active surveillance of approximately 48,000 study participants in eight European countries (Austria, Czech Republic, Finland, France, Germany, UK, Poland and Sweden). Due to the high proportion of women aged 40 and above, an age restriction was implemented after about 2 years of recruitment; since then, only women aged below 40 years are eligible for participation. Women are enrolled by health care providers and complete a questionnaire including questions on their socio-economic status (country specific values) and individual sexual behavior. Patients receive 5 follow-up questionnaires within 3 years. All patient-reported outcomes of interest are validated with the treating physician. Results: 37,186 women had been recruited by end of August 2017; thereof 4,361 (12%) Jaydess users, 20,494 (55%) Mirena users and 11,428 (31%) CU-IUD users. Cohorts differed substantially by user status: 81% of Jaydess users had never used any IUD before, compared to 46% of Mirena and 63% of CU-IUD users. Jaydess users were considerably younger than users of other IUDs (mean age 27.1 years vs. 36.8 years in Mirena and 32.3 years in CU-IUD users). 65% of Jaydess users were nulliparous compared to 14% of Mirena and 35% of CU-IUD users. Of parous Jaydess users, 28% were breastfeeding at time of insertion, whereas the proportion in the other cohorts was lower: 12% of parous Mirena and 20% of parous CU-IUD users. Conclusions: In the EURAS-LCS12 study, the three user cohorts show substantial differences regarding age, parity and user status, as well as showing large differences between the countries. Further sensitivity analysis, including the influence of associated factors, will be done after recruitment is completed.
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