European Active Surveillance Study of LCS12

This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.

Intrauterine contraceptive methods, such as Mirena and copper IUDs, have a high contraceptive efficacy. LCS12 is a new intrauterine system which, like Mirena, contains levonorgestrel (LNG), but the T-body dimensions and insertion tube diameter of LCS12 are smaller. Because there is a lack of comparative data between LCS12 and other intrauterine contraceptives, it is unclear whether there are differences in contraceptive failure rates between LCS12 and either Mirena or copper IUDs. In addition, any transcervical procedure, including the insertion of an intrauterine device, is potentially associated with the risk of infection/inflammation. EURAS-LCS12 is a prospective, controlled, non-interventional, active surveillance cohort study with three user cohorts: LCS12, Mirena and copper IUDs. Study participants will be recruited by a network of health care professionals and will be followed up through active surveillance to collect information regarding the outcomes of interest and major safety outcomes. All self-reported clinical outcomes of interest will be validated by health care professionals. The primary endpoint is unintended pregnancy. Secondary endpoints are ectopic pregnancy, uterine perforation, and pelvic inflammatory disease (PID). Study Amendment (Approved by PRAC on September 29, 2016): The primary objective of the study is to assess the contraceptive failure risk of Jaydess, Mirena, and copper IUD use in a study population that is representative of the real users of the individual IUDs. Interim analysis showed a high proportion of IUD users in the age group \>= 40 years of age. Given the fact that the age distribution remains considerably skewed, and that the Pearl Index is influenced by the age of participants, the independent Safety Monitoring and Advisory Council decided to suggest to narrow the study inclusion criteria, i.e. an age restriction to \<40 years old at study entry was suggested for the remaining recruitment phase. All analyses regarding unintended pregnancies (including ectopic pregnancies) will be conducted using the complete cohorts (i.e. including study participants aged 40 years and older). In addition, these analyses will be done including only women in the age group below 40 years. Further age-stratified analyses of these outcomes are also planned. Study Amendment (Approved by PRAC in February, 2018): In addition, due to concerns regarding the influence of the use of hormonal IUDs on neuropsychiatric disorders, the PRAC requested to investigate the baseline risk as well as the risk under exposure of IUDs within the EURAS-LCS12 study. The baseline questionnaire will capture information on the history of anxiety, panic attacks, mood swings/depression, persistant difficulties with sleeping and restlessness (further on referred to as "neuropsychiatric complaints") for all newly recruited users after ethical approval of the revised questionnaire. Neuropsychiatric complaints that occur under exposure to an IUD re Покажи пълното описание...

Inclusion Criteria: * Women aged below 40 years who have a new IUD inserted (LCS12, Kyleena, Mirena, copper IUD, or any other hormonal IUD) * Women who are willing to participate in the active surveillance Exclusion Criteria: * Women aged 40 or older at insertion day * Women who are currently enrolled in an interventional trial on IUD use can not participate