Health Equity

SW-4G - Seeking the roadmap: Incorporating menstruation and menopause into pharmacoepidemiology research

Tuesday, August 26, 2025

10:30 AM - 12:00 PM ET

Location: 201

Presenting Author(s)

Enriqueta Vallejo-Yagüe, PhD, Pharm

Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland, Switzerland
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Harriet Dickinson, PhD

Real world evidence, Gilead Sciences, Uxbridge, UK., United Kingdom
Adrian Martinez-De la Torre, PhD

Assistant Professor Functioning Epidemiology
Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland, Switzerland
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María Martínez-González, PharmD, MPH

Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
Madrid, Madrid, Spain
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Taichi Ochi

Department of PharmacoTherapy, -Epidemiology and -Economics, Groningen Research Institute of Pharmacy, University of Groningen, Groningen, The Netherlands, Netherlands

Co-Author(s)

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Sieta T. de Vries

University of Groningen, University Medical Center Groningen, Department of Clinical Pharmacy and Pharmacology, Groningen, The Netherlands, Netherlands
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Marleen M. H. J . van Gelder, PhD

IQ Health science department, Radboud university medical center, Nijmegen, The Netherlands, Netherlands

Presenting Author(s)

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Hedvig M.E Nordeng

PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway, Norway

Background: Menstrual cycle and menopause can influence and be influenced by disease and treatment, and interact with wellbeing. For example, chronic diseases flares can be linked to the menstrual cycle (e.g., IBD, lupus); Several medicinal products, including COVID19 vaccines, were associated to menstrual disturbances as adverse drug reactions; Menopause can shift disease risks; And menstrual disorders can take a toll on wellbeing. Despite their broad health implications, research on menstruation and menopause is hindered by stigma, lack of systematic data collection, and methodological challenges, such as the intermittent nature of menstrual cycles, the transition nature of menopause, the large individual variability, and the absence of standardized reporting mechanisms. This workshop brings together the community of stakeholders to address the complexity of integrating the menstrual cycle and menopause into real-world evidence.

Objectives: To increase awareness and build a roadmap to incorporate the menstrual cycle and menopause in the pharmacoepidemiologic study of disease, drug response, and functioning. After providing necessary background, a collaborative interactive exercise seeks to engage the audience with the topic and shape next steps in the field, drafting a roadmap. The workshop is expected to benefit those with interest in gaining a more holistic picture of health and disease burden, as well as those attracted to data, design and statistical challenges.

Description: This session provides an exploration of the role of sex hormones, menstruation, and menopause in health, disease, and treatment, as well as associated challenges and opportunities. Attendees gain insights into emerging research, methodological considerations, and practical applications. Collaborative discussion serves for engagement and road mapping. The workshop starts with necessary background (Introduction, significance and impact; Differential drug responses with menstruation and menopause; Menstrual disturbances as adverse drug reactions; Health and functioning in the context of menstruation and menopause; Menstrual disorders, a case example; And a case example for endometriosis and menopause), followed by an interactive exercise with structured group discussions with predefined topics/challenges (e.g., data; study design; statistics; stigma/bias), a wrap-up and roadmap.