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How the WHIMS clinical trial shaped the future of women’s health research

Nature Reviews Endocrinology volume 21, page 271 (2025)Cite this article

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In 1993, the 103rd United States Congress signed the NIH Revitalization Act into law; prior to this date, women (and members of minority groups) were largely excluded from clinical trials. To this day, women experience more adverse reactions to medication and surgical complications involving medical device implants than men, as the studies regarding the safety and efficacy of medications and devices have largely been conducted in men.

It was not until the early 2000s that women’s health research truly began to gain momentum in the USA, driven in part by an increase in the prevalence of sex-biased diseases, such as Alzheimer disease. Globally, women account for two-thirds of the current population of patients with Alzheimer disease; however, the mechanism underlying the susceptibility of women to Alzheimer disease remains unclear and is likely to be multifactorial. Numerous high-profile studies, the most notable being the Women’s Health Initiative Memory Study (WHIMS), have begun to investigate the role of female sex hormones in this disease.

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References

Original article

  • Shumaker, S. A. et al. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: The Women’s Health Initiative Memory Study: a randomized controlled trial. Obstet. Gynecol. 102, 637–638 (2003)

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  • Miller, V. M. et al. The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned? Menopause 26, 1071–1084 (2019)

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  • Nudy, M., Chinchilli, V. M. & Foy, A. J. A systematic review and meta-regression analysis to examine the ‘timing hypothesis’ of hormone replacement therapy on mortality, coronary heart disease, and stroke. IJC Heart Vasc. 22, 123–131 (2019)

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Acknowledgements

The author would like to thank E. Reed for her assistance in editing and proofreading, and B. Yates for information regarding this submission opportunity.

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  1. School of Biomedical Sciences, Kent State University, Kent, OH, USA

    Phaedra R. Keller-Norrell

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  1. Phaedra R. Keller-Norrell
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Correspondence to Phaedra R. Keller-Norrell.

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The author declares no competing interests.

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Keller-Norrell, P.R. How the WHIMS clinical trial shaped the future of women’s health research. Nat Rev Endocrinol 21, 271 (2025). https://doi.org/10.1038/s41574-025-01101-3

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