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

BACKGROUND: The introduction of a prolonged-release combined oral contraceptive (COC) with 2 mg dienogest (DNG) and 0.02 mg ethinyl-oestradiol (EE) in a 24/4 daily regimen in over 17 countries between 2024 and 2025 has been the result of extensive pharmaceutical research and clinical development. The high level of acceptability of this novel formulation is due to its reliable contraceptive efficacy and cycle control. OBJECTIVE: To describe the incidence of thromboembolic events with the use of the DNG/EE COC based on more than one year of pharmacovigilance data, providing the first indication regarding its safety profile. METHODS: After more than one year of clinical experience and over 50,861 women-years of use, 12 cases of VTE were recorded, resulting in a rate of 2.36 VTE events per 10,000 women-years. CONCLUSIONS: 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.