Despite impacting more than 1.2 billion women worldwide by 20301, perimenopause and menopause remain vastly underrepresented areas in clinical research. Yet these life stages, marked by profound physiological transitions and long-term health implications, presents a compelling opportunity for innovation in therapeutic development.
Elevating Women’s Health through Science, Clinical Strategy, and Purpose
For decades, midlife women have been underserved. Exclusion from trials, inadequate post-market surveillance data, and limited funding for menopause-related research have contributed to the persistent shortage in clinical data needed to drive evidence-based care. As societal awareness grows and regulatory agencies increase focus on sex- and age-inclusive research, the question for biopharma is no longer if we should invest in this space, but how.
At Medpace, we believe that advancing women’s health requires more than incremental change. It demands a reimagining of clinical development strategy, grounded by science, informed by the lived experience of women, and executed with operational precision.
Menopause and the Evolving Landscape of Women’s Health
The menopausal transition is not a singular event, but a multi-year transition with complex interactions across systems— neurological, cardiovascular, metabolic, musculoskeletal, and urogenital. The loss of estrogen and subsequent endocrine shifts affect everything from sleep and cognition to lipid profiles and insulin sensitivity. These are not simply quality-of-life concerns, they are clinical indicators of chronic disease risk.
Despite this knowledge, the translation of this science into drug development has been slow. Historically, women in midlife have been:
- Excluded from clinical trials due to hormonal variability and assumptions about enrollment feasibility
- Underrepresented in safety and efficacy datasets, leading to suboptimal therapeutic decision-making
- Overlooked in funding cycles, where acute or rare conditions have received greater investment than this universal life change
With an aging global population (women over 50 years of age projected to surpass 2 billion by 2080) and increasing demand for holistic, proactive healthcare, the biopharmaceutical sector has an opportunity to address this imbalance.
Clinical Trial Design for the Modern Midlife Woman
To bring meaningful therapies to this population, clinical development must move beyond traditional paradigms. Effective trial design for perimenopausal, menopausal, and postmenopausal women should incorporate:
- Eligibility criteria that align with real-world hormonal transitions
- Patient-reported outcomes that capture cognition, sleep quality, thermoregulation, sexual function, and more
- Longitudinal endpoints that reflect the cumulative impact of estrogen loss on cardiometabolic and bone health
- Leveraging new technologies to disrupt the legacy models of retention and compliance that have failed to consider work, caregiving responsibilities, and symptom burden for women in trial participation
- Personal prescriptive strategies designed around the specific needs of women to ensure there is a plan based on individual assessments
- Diverse and representative enrollment and retention strategies
At Medpace, we bring together board-certified physicians, regulatory strategists, and dedicated operational experts who specialize in the complexities of women’s health. Our full-service model is designed to navigate regulatory expectations, accelerate enrollment, and ensure scientific integrity—across indications and geographies.
“Menopause is not a niche concern, it’s a global health priority,” shares, Rujin Ju, MD, MSCR, FACOG, Medical Director of Women’s Health at Medpace. “As science and society embrace this truth, clinical development must rise to the challenge with evidence-based urgency and insight.”
Global Menopause Day – From Recognition to Action
This Global Menopause Day, we reflect on how far the field has come and how much opportunity remains to enhance the quality of life for women globally.
By incorporating the unique clinical needs of perimenopausal and postmenopausal women into study design, we can improve representation, generate more meaningful insights, and ultimately, support the development of therapies that meet the long-term needs of this population.
At Medpace, we are proud to collaborate with biopharma Sponsors who share this commitment to advancing women’s health. With specialized medical leadership, integrated global operations, and experience across a range of women’s health indications, we help biopharmaceutical companies bring clarity and confidence to clinical development in this evolving space.
Let’s move women’s health forward—together.
Sources:
- Namazi, M., Sadeghi, R., & Behboodi Moghadam, Z. (2019, December 9). Social Determinants of Health in menopause: An integrative review. International journal of women’s health. https://pmc.ncbi.nlm.nih.gov/articles