One-year clinical experience on the thromboembolic safety profile of the first prolonged release combined oral contraceptive containing 2 mg dienogest and 0.02 mg ethinyl-oestradiol

The reported incidence of VTE under the use of DNG/EE is low, lower than the rate defined by the EMA of 5-7 cases per 10,000 women-years under the use of a COC with levonorgestrel or the summary of product characteristics specified VTE risk of 8-11 cases per 10,000 women-years for the combination of DNG/EE, hence introducing a new safe contraceptive option, in particular for users wishing the anti-androgen properties of such a formulation. This first preliminary report further confirms the safety of the product, providing reassurance to both healthcare providers and patients.