Instituto Palacios, Salud y Medicina de la Mujer, C/ Antonio Acuña 9, 28009, Madrid, Spain.
Exeltis HealthCare Madrid. C/ Manuel Pombo Angulo 28, 4thFloor, 28050, Madrid, Spain.
BMC Womens Health. 2020 Oct 2;20(1):218. doi: 10.1186/s12905-020-01080-9.
A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone (DRSP) at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties. The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a contraceptive method with high efficacy and showing a profile with low cardiovascular risks.
Three European and American multicenter clinical trials have been conducted in more than 2500 patients and more than 25,000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41.9%) had a risk factor for VTE, while in the European studies, 261 patients (16.6%) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated.
No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and/or 85 to 90 mm HG and no influence on ECG parameters were observed.
The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors.
EudraCT registration numbers: 2010-021787-15 & 2011-002396-42 . Clincaltrials.gov: NCT02269241 .
一种新的不含雌激素的避孕药已获得 FDA 和 15 个以上欧洲机构的批准。它由屈螺酮（DRSP）组成，剂量为 4 毫克，方案为 24/4。该分子具有抗促性腺激素、抗盐皮质激素、抗雌激素和抗雄激素作用。这些临床试验的目的是引入一种高效的避孕方法，并显示出具有低心血管风险的特征。
已经在超过 2500 名患者和超过 25000 个周期中进行了三项欧洲和美国多中心临床试验，不仅证明了其优异的疗效（Pearl 指数为 0.73），还研究了可能的心血管风险。在美国的研究中，422 名参与者（41.9%）有静脉血栓栓塞（VTE）的风险因素，而在欧洲的研究中，261 名患者（16.6%）有至少一个 VTE 风险因素。评估了动脉和静脉血栓栓塞事件的数量、止血数据、血压变化和心电图数据。
没有记录到 VTE 病例，没有观察到止血参数的变化，在预处理值在 130 到 140 之间和/或 85 到 90mmHg 的患者中 RR 略有下降，没有观察到对心电图参数的影响。
引入一种新的不含雌激素的避孕药，含有 4 毫克非微粒化屈螺酮，方案为 24/4 天，为女性提供了更多的避孕选择，不仅在临床试验中证明了其高效性，而且观察到即使在有心血管风险因素的女性中也具有非常高的心血管安全性。
EudraCT 注册号：2010-021787-15 和 2011-002396-42。Clincaltrials.gov：NCT02269241。
