Disparities in emergency contraceptive metabolism dictate efficacy

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.