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

Abstract

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

Chinese abstract

介绍：一种新的无雌激素避孕药, 在24 + 4的给药方案中使用4mg屈螺酮 (DRSP) , 已经开发出其比尔指数为0.51 (95%CI 0.1054；1.4922), 以下研究的目的是确定与75mg去氧孕烯相比, 4mg DRSP是否对凝血因子和血栓形成风险具有影响。

患者和方法：在9个完整周期中, 39名患者在24 + 4周期中连续接受4mg DRSP和另29名患者每日接受75mg去氧孕烯。评价以下止血参数：Apc抗性, 抗凝血酶III, C反应蛋白, 因子VII, 因子VIII和D-二聚体。

结果：在DRSP组中因子VII从1.123降至1.066, 在去氧孕烯组中因子VII从1.241降至1.034 (p = 0.0088) 。 在DRSP组中平均C反应蛋白从基线到终点的变化差异为0.0332, 而在去氧孕烯组中为0.157 (p = 0.0249) 。DRSP组中的D二聚体值从264.9-215.0ng/mL的基线值下降, 而在去氧孕烯组中, 从201.4ng/mL上升至281.5ng/mL。

讨论：4mg DRSP对止血参数没有任何有意义的改变, 表明其止血效果不明显。

Keywords:

• Hormonal contraception
• ovary
• uterus

Declaration of interest

P.A. Regidor is an employee of Exeltis, Germany; E. Colli is an employee of Exeltis, Spain.