Disparities in emergency contraceptive metabolism dictate efficacy

紧急避孕药代谢的差异决定了功效

基本信息

批准号：
10834696
负责人：
ALISON B EDELMAN
金额：
$ 33.64万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-20 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10834696
关键词：
Address Adolescent Age Attention Award COVID-19 COVID-19 booster COVID-19 impact COVID-19 vaccination COVID-19 vaccine Characteristics Child Clinical Trials Collaborations Contraceptive Agents Control Groups Counseling Data Data Collection Data Set Data Sources Disease Disparity Dose Family Fertility Foundations Funding Gender Goals Grant Health Immune response Individual Intellectual functioning disability Knowledge Length Level of Evidence Longitudinal cohort Measures Mediating Menstrual cycle Menstruation Metabolism Monitor Morbidity - disease rate National Institute of Child Health and Human Development Outcome Ovulation Parents Patient Outcomes Assessments Patient-Focused Outcomes Peer Review Personal Satisfaction Phase Population Prospective cohort Publications Recommendation Reporting Research Resolution Surveys Teenagers Time Vaccination Vaccines Woman Work booster vaccine clinically significant cohort cytokine data access data de-identification design digital digital technology emergency contraception evidence base experience girls health knowledge hypothalamic pituitary ovarian axis interest large datasets mortality physically handicapped pregnant proliferative phase Menstrual cycle prospective public health emergency reproductive response sex unvaccinated vaccine hesitancy vaccine trial young adult

项目摘要

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.

项目概要一半的人口会经历月经、正在经历月经或曾经经历过月经。月经大约每个月出现一周，持续 40 年——人一生中相当长的一段时间月经健康（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能力一般指标的重要性。结果通常不包含在临床试验中，也没有成为疫苗试验的考虑因素。许多关于接种 COVID-19 疫苗后出现月经紊乱的报告，但完全没有证据，以及对这一特定性别问题缺乏关注导致了对疫苗的犹豫，导致公众的不信任并直接影响可预防的发病率和死亡率。前瞻性人口水平数据，以确定 COVID-19 疫苗暴露基线（第 1 剂和第 2 剂）以及没有其他关于月经相关结果的预期人口水平数据集。任何针对月经周期的疫苗。我们的大型前瞻性队列是作为限时 NICHD 补充（R01HD089957 PI Edelman）“新冠肺炎疫苗接种和月经”，截至 2022 年 6 月。总体目标申请，响应特别关注通知“冠状病毒的新出现和现有问题与妇女、儿童和个人健康和福祉相关的 2019 年疾病 (COVID-19) 研究具有身体和/或智力障碍”（NOT-HD-22-002），是继续利用我们独特的大群体进一步了解接触 COVID-19 疫苗对解决周期紊乱的影响 6 疫苗接种后几个月，在青少年和避孕药具使用者等关键亚人群中，以及额外的我们拥有数据集并可以访问其他数据收集来扩展我们的疫苗剂量（“加强剂”）。超出我们的补充拨款目标的分析也使我们能够我们的团队得到了持续的承诺，迅速应对不断变化的公共卫生紧急情况。两个领先的在线月经周期跟踪平台具有内置的用户批准，可以提供这种de- 识别用于研究目的的数据以及调查这些用户以获得额外数据的能力。