The HRT Boomerang: The Rise, Fall, and Rise again of Hormone Replacement Therapy for Menopause

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Black box warnings are the most severe regulatory alerts used by the Food and Drug Administration (FDA), reserved for medications with life-threatening risks.^[1] In 2003, they were affixed to all menopausal Hormone Replacement Therapy (HRT) products containing estrogen, a treatment that had been available for decades.^[2] The FDA mandated the warnings after the Women’s Health Initiative (WHI) study – the largest women’s health study ever conducted in the United States – found that HRT increased women’s risk for invasive breast cancer, disrupting decades of public and medical opinion overnight. In the decades preceding the WHI’s publication, the drugs were commonplace; doctors prescribed HRT without much apprehension, and women were generally able to easily access and take HRT without anxiety. The 2002 findings left both women and their physicians wary of HRT.^[3]

Yet, on November 10, 2025, the United States Department of Health and Human Services announced a groundbreaking update to women’s health policy. The FDA would remove broad black box warnings from HRT products for menopause.^[4] The shift emerged following a swell of fresh conversations about menopause and pro-HRT advocacy acknowledging flaws of the WHI study, specifically its design, interpretation, and misrepresentation of results. Among the two chief concerns were that the findings regarding breast cancer were not statistically significant, and that the study did not actually represent the population it was designed to help given its demographic of mostly post-menopausal women.^[5]

HRT reentered public discourse at a peculiar medical moment, amidst an otherwise tumultuous, even catastrophic, time in health policymaking. It is a curious aberration that this against-the-tide development has emerged whilst broader reproductive autonomy is under siege. Although this decision may feel like an incredulous victory for women in the context of HRT’s disrepute, it aligns with HRT’s historical precedent of fluctuating favorability in medical and social spheres alike. HRT represents a complex focal point in feminist medicine, exposing rifts in the women’s health movement’s confrontation with (white) male medical authority.

Menopause has long existed within a double taboo. It compounds the stigma of menstruation and women’s reproductive health with ageism. Middle-aged women who experience the transition are invisibilized and disregarded by mainstream media and medicine. More stigmatized than menopause itself, though, is its management. HRT for menopause owes its reputation to pharmaceutical and scientific missteps and smear campaigns that reinforced misunderstanding and fear. Throughout its golden ages and downfalls, HRT’s intense pendulum swings demonstrate how, regardless of whether the drugs are in favor, sexism and ageism have always underpinned the attitudes of medicine, science, and the public.

HRT for menopause, also known as Menopausal Hormone Therapy, refers to prescription drug forms of estrogen, progestin, or combination estrogen-progestin medications. HRT can help to reduce symptoms of menopause, improve women’s quality of life, and is potentially protective against chronic disease, such as cardiovascular disease, the risk of which rises substantially in post-menopausal years.^[6] Additionally, HRT can have a range of other preventative health benefits including improving bone health, brain health, and preventing genito-urinary syndrome of menopause.^[7] Despite compelling evidence that HRT for menopause is a safe and effective option, it is wildly underutilized. Today, less than five percent of women in the United States take HRT for menopause.^[8] HRT skepticism has spanned decades and created a climate of judgment and ignorance that affects whether and how women choose to manage their health.

From the mid-twentieth century onward, pharmaceutical companies were extraordinarily influential in driving the popularity of HRT drugs. Aggressive marketing ploys fueled this first “golden age.” In 1966, bankrolled by pharmaceutical companies producing HRT, Dr. Robert Wilson published his infamous book Feminine Forever. In this best-seller, the gynecologist framed menopause as a “deficiency disease,” classifying the process as unnatural but reversible with estrogen.^[9] Misogynistic quips and inflammatory language rife throughout the book (including calling his own menopausal mother a “pain-racked, petulant invalid,”) stoked urgency.^[10] HRT became the default for menopause management; one figure from the Department of Commerce estimated that the estrogen market rose from $17 million in 1962 to $69 million in 1973.^[11]

One company, Wyeth-Ayerst, shaped the medical landscape by putting out physician and direct-to-consumer advertisements, which mobilized anxieties and stigma against older women as a marketing strategy. Their star product was Premarin, which derived its brand name from the origin of conjugated estrogen: pregnant mares’ urine. Advertisements presented Premarin as salvation for older women and preyed upon women’s fears of dissolving into unattractive, unfeminine, and dysfunctional people. Many ads spoke directly to the physician, the husband, and the family rather than the patient and consumer herself, proclaiming “husbands love Premarin,” or “help keep her this way.”^[12] Women needn’t fear that they were “outliving their ovaries,” or that they were becoming “defeminized,” so long as they followed medical advice and began an HRT regimen.^[13] In depicting exclusively white, usually well-off, women, in their advertisements, Wyeth-Ayerst coded femininity and youthfulness as intrinsically classed and raced.

By the 1970s, women’s health advocates questioned the hold of the male-dominated medical establishment on menopause. They viewed HRT as an extreme intervention, peddled to them by the very institutions generating aging insecurity. Instead, women sought guidance from each other. Feminist works like Menopause, a Positive Approach by Rosetta Reitz were a stark contrast to Feminine Forever.^[14] They re-conceptualized menopause as a natural process, dispelled blanket HRT recommendations, and often opposed HRT entirely. Prioritizing lifestyle changes and holistic HRT alternatives (among them, health food diets and bee pollen supplements) reflected feminist desire to use channels outside the mainstream, and increasingly, to forge their own channels to manage their menopausal experience.^[15] The topic of menopause did not even appear in the 1970 edition of the iconic source of women’s health information, Our Bodies, Ourselves, by the Boston Women’s Health Book Collective.^[16] However, in 2006, they published a special edition, Our Bodies, Ourselves: Menopause, which echoed earlier feminist framings of menopause as a natural transition and rejected its medicalization.

From the 1950s through the 1970s, HRT was cast as a means of guaranteeing femininity, and thus, value. But in the 1980s and 1990s, HRT was rebranded as a means of guaranteeing health. In the mid-1970s, several studies linked HRT use (specifically estrogen) to elevated rates of uterine cancer, which marred the treatment’s reputation and led to a sharp decline in prescriptions. However, beginning in the 1980s, HRT experienced a resurgence after combination estrogen-progesterone therapy was found to reduce endometrial cancer risk. Simultaneously, observational studies like the Nurses’ Health Study suggested that HRT could protect against chronic illness, especially heart disease and osteoporosis.^[17] By 1992, Premarin would become the best-selling drug in America.^[18] The second golden age of HRT was now in full swing: nearly half of all postmenopausal women in the United States were prescribed long-term HRT.^[19]

In spite of the boom in HRT use, many women who viewed the drugs as a tool of the male-dominated medical and pharmaceutical industries remained skeptical. Feminists understood the dearth of research surrounding HRT for menopause and women’s long-term health as another offense in the long-standing tradition of medicine dismissing women. To address these gaps, women sought partnership with governing scientific bodies and lobbied for their inclusion in medical research. The landmark WHI study, launched in 1991, was a direct product of feminist health advocacy.

The WHI was a randomized, double-blind, placebo-controlled trial, a study design regarded as the gold standard. The study consisted of three clinical trials, with the HRT arm of the study aiming to discern whether HRT could stave off chronic disease in older women, improve their quality of life and lifespan, and, fundamentally, determine whether HRT was dangerous. It remains the largest women’s health study ever conducted, enlisting more than 161,000 total participants.^[20] The study was planned to span eight and a half years. However, in July of 2002, the study was halted abruptly due to concerns about HRT’s safety, namely increased invasive breast cancer risk.^[21] Menopause may not have been mainstream, but sensationalist HRT reporting was, as reporters raced to expose “The Truth About Hormones.”^[22] Alarmist stories made front page news and were printed en masse, cautioning women about their newfound breast cancer risk. Yet, this takeaway was based on inaccurate representations of WHI results. This included the WHI’s use of relative risk instead of absolute risk in reporting on coronary heart disease and invasive breast cancer risks.^[23] If, as purported by WHI authors, HRT really was so harmful to postmenopausal women’s health, the steep reduction in use would have vastly improved women’s health.^[24]

HRT would suffer an abrupt fall from grace: within five months of the WHI trial’s early termination, HRT use declined by 46% in the United States.^[25] Exaggerated media reports neglected to disclose, however, that the WHI’s study design and interpretation have proven to be deeply flawed. Unlike the popularized conclusions reported in the WHI study press release and subsequent news headlines, the actual publication of the results in the Journal of the American Medical Association reported no statistically significant difference in the rates of breast cancer among women on HRT versus women on a placebo.^[26] Study participants also ranged in age from 50 to 79, averaging an age of 63 (meaning most participants were staunchly post-menopause).^[27] The study also excluded women with significant menopause-related complaints, meaning the WHI study misrepresented why women were taking HRT, and who was actually taking HRT.^[28] Women were left angry and fearful: the news confirmed longstanding frustration with the medicalization of menopause. The misinterpretation of WHI study results, widespread media attention, declining industry promotion, and decreased patient demand all seemed to be nails in HRT’s coffin.

Harmful after-effects have persisted beyond 2002, through generations of perimenopausal, menopausal, and postmenopausal women. Prescriptions plummeted, as medical education about HRT all but disappeared. A 2023 survey of Obstetrics and Gynecology medical residency programs found that just 31 percent have a formal menopause curriculum.^[29] Beyond HRT acquiring a tainted reputation, health outcomes for women also suffered. One estimation projected a mortality toll of nearly 50,000 hysterectomized women who died prematurely from 2002-2011 after avoiding estrogen. It is a cruel irony that the study women lobbied for has so deleteriously impacted women’s health. News of the study breaking in 2002 derailed HRT’s second golden age because it confirmed the failure of science, medicine, media, and industry to serve women.

The boomerang effect of HRT’s rise, fall, and rise again has had tangible negative impacts on women’s health. A group of outspoken advocates – particularly women specializing in urology, gynecology, and menopause – have entered the political arena and created a groundswell of support for an evidence-based approach to menopause care. Signs of HRT’s renewed acceptance in the 2020s point towards an uncharacteristic, if not isolated, acknowledgment of women’s right to live out the second half of their lives in good health and comfort. It is unclear whether this correction will be powerful enough to disrupt entrenched fears from the public and medical sphere. Given the decades-long pattern of vacillating sentiments towards the drugs, HRT may one day find itself back in medical limbo.

Notes

1. “What Is a Black Box Warning? | Johns Hopkins | Bloomberg School of Public Health,” December 19, 2025, https://publichealth.jhu.edu/2025/what-is-a-black-box-warning. ↑
2. FNU Zeeshan and Ali Saqlain, “FDA’s 2025 Removal of Black Box Warnings on Menopausal Hormone Therapy,” Annals of Medicine and Surgery 88, no. 2 (2026): 2222–23, https://doi.org/10.1097/MS9.0000000000004749. ↑
3. Sumit R. Majumdar et al., “Promotion and Prescribing of Hormone Therapy After Report of Harm by the Women’s Health Initiative,” JAMA 292, no. 16 (2004): 1983–88, https://doi.org/10.1001/jama.292.16.1983. ↑
4. Robert F. Kennedy Jr, “Advancing Women’s Health,” 2025, U.S. Department of Health and Human Services (HHS), https://www.youtube.com/watch?v=x7YJo-Ho2eo. ↑
5. Writing Group for the Women’s Health Initiative Investigators, “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial,” JAMA 288, no. 3 (2002): 321–33, https://doi.org/10.1001/jama.288.3.321. ↑
6. M. Gambacciani et al., “Hormone Replacement Therapy and Prevention of Chronic Conditions,” Climacteric: The Journal of the International Menopause Society 22, no. 3 (2019): 303–6, https://doi.org/10.1080/13697137.2018.1551347. ↑
7. Marcela Treviño et al., “Comparative Effects of Hormone Replacement Therapy and Exercise on Bone Health in Postmenopausal Women: A Systematic Review,” Cureus 17, no. 12 (n.d.): e99210, https://doi.org/10.7759/cureus.99210. ↑
8. Samantha Anderer, “Only About 5% of US Women Now Use Menopausal Hormone Therapy,” JAMA 332, no. 21 (2024): 1779, https://doi.org/10.1001/jama.2024.22564. ↑
9. Robert Wilson, M.D., Feminine Forever (M. Evans and Company, INC., 1966). ↑
10. Wilson, M.D., Feminine Forever, 196. ↑
11. “Estrogen ‘Prime Suspect’ in Over-50 Cancer Rise,” Patriot (Harrisburg, Pennsylvania) 134, October 31, 1975: 18. Readex: America’s Historical Newspapers. ↑
12. Premarin advertisement for Ayerst Laboratories, Obstetrics & Gynecology, Ebling Library CollectionHealth Advertisements Database, accessed June 2026, https://search.library.wisc.edu/search/digital?q=Premarin. ↑
13. Premarin advertisement for Ayerst Laboratories, Obstetrics & Gynecology. ↑
14. Rosetta Reitz, Menopause: A Positive Approach (Penguin Books, 1979.) ↑
15. Rosetta Reitz, Menopause, 190. ↑
16. The Boston Women’s Health Book Collective, Our Bodies, Ourselves: Menopause. ↑
17. M. J. Stampfer et al., “A Prospective Study of Postmenopausal Estrogen Therapy and Coronary Heart Disease,” The New England Journal of Medicine 313, no. 17 (1985): 1044–49, https://doi.org/10.1056/NEJM198510243131703. ↑
18. D. K. Wysowski et al., “Use of Menopausal Estrogens and Medroxyprogesterone in the United States, 1982-1992,” Obstetrics and Gynecology 85, no. 1 (1995): 6–10, https://doi.org/10.1016/0029-7844(94)00339-f. ↑
19. Sumit R. Majumdar et al., “Promotion and Prescribing of Hormone Therapy After Report of Harm by the Women’s Health Initiative,” JAMA 292, no. 16 (2004): 1983–88, https://doi.org/10.1001/jama.292.16.1983. ↑
20. “Women’s Health Initiative (WHI) | NHLBI, NIH.” ↑
21. NIH News Release-NHLBI Stops Trial of Estrogen Plus Progestin Due to Increased Breast Cancer Risk, Lack of Overall Benefit, July 9, 2002. ↑
22. Christine Gorman and Alice Park, “The Truth About Hormones,” Time, July 22, 2002, https://content.time.com/time/covers/0,16641,20020722,00.html. ↑
23. John P. Bunker et al., “Putting the Risk of Breast Cancer in Perspective,” BMJ: British Medical Journal 317, no. 7168 (1998): 1307–9, https://doi.org/10.1136/bmj.317.7168.1307. ↑
24. Angelo Cagnacci and Martina Venier, “The Controversial History of Hormone Replacement Therapy,” Medicina 55, no. 9 (2019): Cagnacci and Venier, 3, https://doi.org/10.3390/medicina55090602. ↑
25. Cagnacci and Venier, “The Controversial History of Hormone Replacement Therapy,” 602. ↑
26. Writing Group for the Women’s Health Initiative Investigators, “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial.” ↑
27. R. D. Langer, “The Evidence Base for HRT: What Can We Believe?,” Climacteric: The Journal of the International Menopause Society 20, no. 2 (2017): 91–96, https://doi.org/10.1080/13697137.2017.1280251. ↑
28. Sheldon J. Segal and Luigi Mastroianni Jr., Hormone Use in Menopause and Male Andropause: A Choice for Women and Men (Oxford University Press, 2003). ↑
29. Jennifer T. Allen et al., “Needs Assessment of Menopause Education in United States Obstetrics and Gynecology Residency Training Programs,” Menopause (New York, N.Y.) 30, no. 10 (2023): 1002–5, https://doi.org/10.1097/GME.0000000000002234. ↑

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Featured image courtesy Towfiqu barbhuiya.