Disparities in emergency contraceptive metabolism dictate efficacy

紧急避孕药代谢的差异决定了功效

• 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
• 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

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.

项目摘要 一半的人口将经历月经，经历月经或经历月经。 月经每月大约一周发生40年 - 大量的一生 经过月经健康（周期和男性长度，规律性和体积/流量）是关键 作为健康和生育的一般指标，患者报告的结果超出了其重要性。月经健康 结局通常不包括在临床试验中，也不是疫苗试验的考虑因素。 COVID-19疫苗接种后月经灾害的大量报道，完全没有 证据，以及对这个特定性别问题的缺乏关注会导致疫苗犹豫 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 预期的人群级数据以建立Covid-19-19疫苗暴露的基准（剂量1和2）和 月经相关的结果。关于 月经周期上的任何疫苗。 我们的大型前瞻性队列是作为时间有限的NICHD补充剂（R01HD089957 PI）建立的 Edelman）“ COVID19疫苗接种和月经”，于2022年6月结束。 申请，应对特殊兴趣的通知“冠状病毒的新兴和现有问题 2019年疾病（COVID-19）研究与妇女，儿童和个人的健康和福祉有关 具有身体和/或智力障碍”（非HD-22-002），是继续使用我们独特的大型队列 进一步了解Covid-19-19疫苗暴露对循环疾病解决的影响6 疫苗发生后的月份，在青少年和避孕用户等关键亚群中，还有其他 疫苗剂量（“助推器”）。我们有数据集并访问其他数据集来扩展我们的 分析我们的补充赠款目标超出了我们的目标。潜在数据集的延续还使我们能够 迅速回应了不断变化的公共卫生紧急情况。我们的团队已得到持续的承诺 在两个领先的在线月经周期跟踪平台和内置用户批准中，以提供此功能 确定了用于研究目的的数据，以及调查这些用户以获取其他数据的能力。