Disparities in emergency contraceptive metabolism dictate efficacy

项目摘要 一半的人将经历月经，正在经历月经，或曾经经历过月经。 40年来，月经每月大约一周--相当于人一生中的一段时间 是来月经的。月经健康(月经周期和月经规律，以及月经量/流量)是关键 患者报告的结果超出了其作为健康和生育力一般指标的重要性。月经健康 结果通常不包括在临床试验中，也不是疫苗试验的考虑因素。 大量报告称，在接种新冠肺炎疫苗后出现月经紊乱，完全没有 证据，以及对这一特定性别问题的缺乏关注，导致了疫苗的犹豫不决 公众不信任，并直接影响可预防的发病率和死亡率。我们的初步数据是第一个 预期人群水平数据，以建立新冠肺炎疫苗暴露(剂量1和2)和 与月经有关的结局。没有其他预期的人口水平数据集存在于 任何月经周期的疫苗。 我们的大型预期队列是作为限时NICHD补充方案(R01HD089957 PI)的一部分而建立的 埃德尔曼)“COVID19疫苗接种和月经”，2022年6月结束。这个项目的总体目标是 应特别关注通知申请“冠状病毒新出现和存在的问题” 疾病2019年(新冠肺炎)与妇女、儿童和个人健康福祉相关的研究 (非HD-22-002)将继续利用我们独特的大队列 进一步了解新冠肺炎疫苗接种对解决周期紊乱的影响6 在疫苗接种后几个月，在青少年和避孕药使用者等关键亚群中，以及在其他 疫苗剂量(“加强剂”)。我们拥有数据集和访问其他数据集合的权限，以扩展我们的 分析超出了我们的补充拨款目标。预期数据集的继续也使我们能够 快速应对瞬息万变的公共卫生突发事件。我们的团队已经收到了持续的承诺 两个领先的在线月经周期跟踪平台，具有内置的用户批准，以提供这一去- 为研究目的确定的数据，以及对这些用户进行调查以获得其他数据的能力。

Project Summary Half the population will experience menstruation, is experiencing menstruation, or did experience menstruation. Menstruation occurs for approximately a week each month for 40 years - a substantial amount of one’s lifetime is spent menstruating. Menstrual health (cycle and menses length, regularity, and volume/flow) is a key patient-reported outcome beyond its importance as a general indicator of health and fertility. Menstrual health outcomes are not routinely included in clinical trials and have not been a consideration for vaccine trials. Numerous reports of menstrual disturbances following COVID-19 vaccination, the complete absence of evidence, and the lack of attention on this gender-specific issue contributes to vaccine hesitancy, causes public mistrust and directly impacts preventable morbidity and mortality. Our preliminary data is the first prospective population-level data to establish baselines for COVID-19 vaccine exposure (dose 1 and 2) and menstrual-related outcomes. No other prospective population level dataset exists with regard to the impact of any vaccine on the menstrual cycle. Our large prospective cohort was established as part of a time limited NICHD supplement (R01HD089957 PI Edelman) “COVID19 vaccination and Menstruation” which ended June 2022. The overall objective for this application, in response to the Notice of Special Interest “ Emerging and Existing Issues of Coronavirus Disease 2019 (COVID-19) Research Related to the Health and Well-Being of Women, Children and Individuals with Physical and/or Intellectual Disabilities” (NOT-HD-22-002), is to continue utilizing our unique large cohort to further understand the impact of COVID-19 vaccine exposure on the resolution of cycle disturbances 6 months post-vaccine, in key subpopulations like adolescents and contraceptive users, and with additional doses of vaccine (‘boosters’). We have the datasets and access to additional data collection to expand our analyses beyond our supplement grant aims. The continuation of the prospective data set also enables us to rapidly respond to an ever-changing public health emergency. Our team has received the ongoing commitment of two leading online menstrual cycle tracking platforms with the built-in user approval to provide this de- identified data for research purposes plus the ability to survey these users to obtain additional data.