Universiteit Leiden

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Research project

Study of utilization of combined hormonal contraceptives in Europe

Combined hormonal contraceptives (CHC) are associated with an increased risk of venous thromboembolism (VTE). In 2013, a review was published by the European Medicines Agency (EMA). In this review, the authors concluded that the risk of VTE varies by the type of progesterone in the CHC. Subsequently, the European Commission adopted on 16 January 2014 a legally binding decision to update the product information of all CHC throughout the European Union. This information included information to patients: awareness of factors that increase the risk of VTE; and information to health care professionals: the type of CHC with the lowest VTE risk (levonorgestrel, norethisterone, or norgestimate). Research question and objectives: The aim of the study is to assess whether the publication of the review by EMA and the legally binding decision to update the product information in January 2014, led to a change in CHC prescription patterns in Europe and, if so, if there was a subsequent change in the incidence rate of VTE.

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