Impact of body mass index on suppression of follicular development and ovulation using a transdermal patch containing 0.55-mg ethinyl estradiol/2.1-mg gestodene: a multicenter, open-label, uncontrolled study over three treatment cycles
Impact of body mass index on suppression of follicular development and ovulation using a transdermal patch containing 0.55-mg ethinyl estradiol/2.1-mg gestodene: a multicenter, open-label, uncontrolled study over three treatment cycles
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DOI：
10.1016/j.contraception.2014.04.018
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发表时间：
2014-09-01
期刊：
影响因子：
2.9
通讯作者：
Merz, Martin
中科院分区：
文献类型：
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作者：
Westhoff, Carolyn L.;Reineeke, Isabel;Merz, Martin
背景：体重指数（BMI）可能影响经皮激素给药引起的排卵抑制。研究设计：这项开放标签，非对照，2b期试验根据三个BMI组（组1，n=56，30 kg/m2和35 kg/m2）分层173名妇女（18-35岁）。妇女使用含有0.55毫克炔雌醇（EE）和2.1毫克孕二烯酮（GSD）的避孕贴片。EE/GSD贴剂每周使用一次，持续3个28天的周期（每周一次贴剂，连续3周，然后是7天的无贴剂间隔），并通过Hoogland评分评估其对排卵的影响，Hoogland评分是一种综合评分，包括经阴道超声和雌二醇（E-2）和孕酮水平，在周期2和3中每3天一次。药代动力学参数评价是本研究的次要目的，在治疗前周期、周期2和周期3采集用于分析测定EE、GSD和性激素结合球蛋白的血样。使用日记信息和血清药物levels.Results的依从性进行评估：在每协议集，只有6个排卵在研究期间，没有参与者排卵在两个研究周期。第1组发生1次排卵，第2组发生3次，第3组发生2次。排卵抑制不受BMI的影响;在所有组中，大多数参与者的Hoogland评分为1或2（即，卵泡样结构
Background: Body mass index (BMI) may influence ovulation inhibition resulting from transdermal hormone delivery. Investigation of this effect is important given the high prevalence of obesity in the US.Study Design: This open-label, uncontrolled, Phase 2b trial stratified 173 women (18-35 years) according to three BMI groups (Group 1, n=56, 30 kg/m(2) and 35 kg/m(2)). Women used a contraceptive patch containing 0.55-mg ethinyl estradiol (EE) and 2.1-mg gestodene (GSD). The EE/GSD patch was used weekly for three 28-day cycles (one patch per week for 3 consecutive weeks followed by a 7-day, patch-free interval), and its effect on ovulation was assessed by the Hoogland score, a composite score that comprises transvaginal ultrasound and estradiol (E-2) and progesterone levels every 3 days in Cycles 2 and 3. Evaluation of pharmacokinetic parameters was a secondary aim of the study, and blood samples for analytic determination of EE, GSD and sex hormone-binding globulin were taken during the pretreatment cycle, Cycle 2 and Cycle 3. Compliance was assessed using diary information and serum drug levels.Results: In the per-protocol set, there were only six ovulations during the study, and no participant ovulated in both study cycles. One ovulation occurred in Group 1, three in Group 2 and two in Group 3. Ovulation inhibition was unaffected by BMI; in all groups, most participants had Hoogland scores of 1 or 2 (i.e., follicle-like structures