Disparities in emergency contraceptive metabolism dictate efficacy

项目摘要 一半的人会经历月经，正在经历月经，或者经历过月经。 月经每月大约有一周，持续40年--这是一个人一生中相当长的时间 都是在浪费时间月经健康（周期和月经长度、规律性和量/流量）是关键 患者报告的结果超出了其作为健康和生育力的一般指标的重要性。经期健康 临床试验通常不包括结果，疫苗试验也不考虑结果。 大量关于COVID-19疫苗接种后月经失调的报告， 证据，以及对这一性别特异性问题缺乏关注，导致疫苗犹豫不决， 公众不信任，直接影响可预防的发病率和死亡率。我们的初步数据是 前瞻性人群水平数据，以建立COVID-19疫苗暴露（第1剂和第2剂）的基线， 相关结果。关于以下因素的影响，没有其他前瞻性人群水平数据集 对月经周期的影响 我们的大型前瞻性队列是作为有时限的NICHD补充的一部分建立的（R 01 HD 089957 PI Edelman）“COVID 19疫苗接种和月经”，截至二零二二年六月。总体目标是 申请，以回应特别关注的通知“新出现的和现有的冠状病毒问题 疾病2019（COVID-19）与妇女，儿童和个人的健康和福祉相关的研究 身体和/或智力残疾”（NOT-HD-22-002），是继续利用我们独特的大型队列 进一步了解COVID-19疫苗暴露对解决周期扰动的影响6 在关键亚群如青少年和避孕药具使用者中， 疫苗（“助推器”）。我们拥有数据集并可以访问其他数据收集， 超出我们补助金目标的分析。前瞻性数据集的延续也使我们能够 快速应对不断变化的突发公共卫生事件。我们的团队已经收到了持续的承诺， 的两个领先的在线月经周期跟踪平台与内置的用户批准，以提供这种去， 用于研究目的的识别数据，以及调查这些用户以获得更多数据的能力。

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.