OBJECTIVE:To investigate the efficacy, cycle control and tolerability of a phasic oral contraceptive containing ethinylestradiol 35/30/30 microg and desogestrel 50/100/150 microg. METHODS:A multicenter study was conducted involving 2070 healthy, fertile women, who received study treatment for six treatment cycles. RESULTS:Most of the participants (79%) had previously been using an alternative oral contraceptive. In 10,408 treatment cycles, two women became pregnant while on treatment (Pearl index, 0.25). The incidence of irregular bleeding was 10% before treatment, rising to 27% at cycle 1, and decreasing to 11% by cycle 6. Irregular bleeding was mainly due to spotting rather than breakthrough bleeding and the incidence of breakthrough bleeding remained below 2.2% for most of the study period. Only 1.8% of women withdrew due to bleeding irregularities. First-time oral contraceptive users initially experienced more irregular bleeding than switchers but these differences lessened over time. The most common adverse events during treatment were headache, breast tenderness and nausea. The incidence of these adverse events fell to below pretreatment levels with continued use. CONCLUSION:The phasic preparation was effective and well tolerated.

译文

目的:研究一种含有炔雌醇35/30/30微克和地索孕酮50/100/150微克的阶段性口服避孕药的疗效,周期控制和耐受性。
方法:进行了一项多中心研究,涉及2070名健康,受孕的妇女,这些妇女接受了六个治疗周期的研究治疗。
结果:大多数参与者(79%)以前一直在使用其他口服避孕药。在10,408个治疗周期中,两名妇女在接受治疗时怀孕(Pearl index,0.25)。治疗前不规则出血的发生率是10%,在第1周期上升到27%,到第6周期下降到11%。大部分学习期间。只有1.8%的妇女因不规则出血而退出。初次口服避孕药的使用者最初比不使用切换器的人发生更多的不规则出血,但是随着时间的流逝,这些差异逐渐减少。治疗期间最常见的不良事件是头痛,乳房胀痛和恶心。通过持续使用,这些不良事件的发生率降至治疗前水平以下。
结论:分期制剂有效,耐受性好。

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