Drospirenone as estrogen-free pill and hemostasis: coagulatory study results comparing a novel 4 mg formulation in a 24 + 4 cycle with desogestrel 75 μg per day

INTRODUCTION: A novel estrogen free contraceptive pill, with drospirenone 4 mg in a dosing regimen of 24 + 4, has been developed with a pearl-index of 0.51 (95% CI 0.1054; 1.4922). The aim of the following study was to determine if 4 mg DRSP has an impact on coagulation factors and thrombotic risks in comparison with desogestrel 75 μg. PATIENTS AND METHODS: Thirty-nine patients received 4 mg DRSP 24 + 4 d and 29 desogestrel 75 μg per day continuously during nine complete cycles. Following hemostatic parameters were evaluated: Apc resistance, Antithrombin III, Protein C reactivity, Factor VII, Factor VIII, and d-Dimer. RESULTS: Factor VII decreased from 1.123 to 1.066 in the DRSP group and from 1.241 to 1.034 in the desogestrel group (p = 0.0088). The difference in change of mean Protein C activity from baseline to endpoint was -0.0332 in the DRSP versus -0.157 in the desogestrel group (p = 0.0249). d-Dimer values dropped in the DRSP group from baseline values of 264.9-215.0 ng/mL, whereas in the desogestrel group there was a rise from 201.4 ng/mL to 281.5 ng/mL. DISCUSSION: DRSP 4 mg was not associated with any meaningful changes on hemostatic parameters, indicating a lack of effect on hemostasis.