Women’s Health Initiative

Women’s Health Initiative

“The Women’s Health Initiative (WHI)
is a long-term national health study funded by the
National Heart, Lung, and Blood Institute, or NHLBI”.1

Date

What can it be important to be clear about with hormone therapy (HT) information?

It can be important to be clear about the date of all information including the date of HT information, because this information may have been updated.

Symptoms or Chronic Conditions

What can it also be important to be clear about with HT information?

It can also be important to be clear about whether HT information is about the use of HT for the management of menopausal symptoms such as hot flushes, night sweats and vaginal dryness; or for the prevention of chronic conditions such as cardiovascular disease, cancers, and osteoporotic fractures.

Women’s Health Initiative

What is the (United States) Women’s Health Initiative (WHI)?

In About WHI the WHI elaborate on:

“The Women’s Health Initiative (WHI) is a long-term national health study funded by the National Heart, Lung, and Blood Institute, or NHLBI”.2

Goal

What was the goal of the WHI?

In Women’s Health Initiative (WHI): What Is the Goal of the WHI? the (United States) National Heart, Lung, and Blood Institute (NHLBI) explain:

“The Women’s Health Initiative (WHI), sponsored by the National Heart, Lung, and Blood Institute (NHLBI), is a long-term national health study that focuses on strategies for preventing heart disease, breast and colorectal cancer, and osteoporosis in postmenopausal women. These chronic diseases are the major causes of death, disability, and frailty in older women of all races and socioeconomic backgrounds”.3

Original WHI Study Dates

When was the original WHI study?

In About WHI the WHI note:

“The original WHI study began in the early 1990s and concluded in 2005”.4

Original WHI Study

In the original WHI study, what were the three parts?

In Women’s Health Initiative (WHI): What Is the Goal of the WHI? the NHLBI explain:

“The original WHI study had three parts—a clinical trial, an observational study, and a community prevention study—and completed data collection in 2005”.5

Heart Disease

What did the WHI find about hormone replacement therapy and heart disease?

In Women’s Health Initiative (WHI): At A Glance the NHLBI note:


  • “The WHI found that hormone replacement therapy did not prevent heart disease in postmenopausal women as once thought”.6

Hormone Replacement Therapy

What did the WHI’s first results in 2002 for hormone replacement therapy (HRT) show?

In The Controversial History of Hormone Replacement Therapy: Abstract the authors elaborate on:

“After the announcement of the first results of the Women’s Health Initiative (WHI) in 2002, which showed that HRT had more detrimental than beneficial effects, HRT use dropped. The negative results of the study received wide publicity, creating panic among some users and new guidance for doctors on prescribing HRT. The clear message from the media was that HRT had more risks than benefits for all women. In the following years, a reanalysis of the WHI trial was performed, and new studies showed that the use of HRT in younger women or in early postmenopausal women had a beneficial effect on the cardiovascular system, reducing coronary disease and all-cause mortality. Notwithstanding this, the public opinion on HRT has not changed yet, leading to important negative consequences for women’s health and quality of life”.7

Extension Studies

What are the WHI’s extension studies?

In About WHI the WHI explain:

“Since 2005, the WHI has continued as Extension Studies, which are annual collections of health updates and outcomes in active participants. The second Extension Study enrolled 93,500 women in 2010 and follow-up of these women continues annually”.8

Extension Studies Main Areas of Research

What are the extension studies main areas of research?

In About WHI the WHI elaborate on:

“As with the original WHI study, the main areas of research are cardiovascular disease, cancers, and osteoporotic fractures. While WHI continues to focus on strategies to prevent the major causes of death, disability, and frailty in older women, the breadth and richness of the WHI data allow for the exploration and investigation of many more research questions on women’s health and aging”.9

Chronic Disease Prevention

What do the authors conclude about the prevention of cardiovascular disease or other chronic diseases in The Women’s Health Initiative Randomized Trials and Clinical Practice, published 01 May 2024?

In The Women’s Health Initiative Randomized Trials and Clinical Practice: Abstract – Conclusions and Relevance the authors conclude:

“For postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases”.10

On page four of Menopause and Menopause Hormone Therapy: 2. What Is MHT? the International Menopause Society’s (IMS) Leaflet for Women for World Menopause Day 2024 on the 18 October, the IMS note:

Women’s Health Initiative

Vasomotor Symptoms

What do the authors conclude about vasomotor symptoms in The Women’s Health Initiative Randomized Trials and Clinical Practice?

In The Women’s Health Initiative Randomized Trials and Clinical Practice: Abstract – Conclusions and Relevance the authors conclude:

“Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy”.11

November 2025 WHI Response

What is the WHI’s response to the proposed FDA removal of black box warning on hormonal therapies?

In News From the WHI Study. WHI Responds To FDA Removal of Black Box Warning on Hormonal Therapies, dated 11 November 2025, the WHI elaborate on:

“Our original conclusions still stands: oral menopausal hormone therapy should not be used for chronic disease prevention. Using menopausal hormone therapy for relief of moderate to severe vasomotor symptoms is reasonable but it should be limited to the lowest dose for the shortest time needed for this indication”.12

Health Care Provider

What if I choose to use HT?

In Menopause Hormone Therapy: Is It Right for You? The Bottom Line: Menopause Hormone Therapy Isn’t All good or All Bad, dated 18 April 2025, the (United States) Mayo Clinic include:

“As researchers learn more about menopause hormone therapy and other menopause treatments, recommendations may change. But if you have menopause symptoms that disrupt your sleep or get in the way of daily life, it’s worthwhile to talk to your healthcare professional about treatment options.

If you’re already taking menopause hormone therapy, check in with your healthcare professional regularly to reassess your need for treatment”.13

Health Topics A-Z

Where may I find Health Topics A-Z related to the Women’s Health Initiative?

In Health Topics A-Z you may find:

Health Topics A-Z

Links

Where may I find Links related to Women’s Health Initiative?

Your Country may have Links similar to:

Links

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U.S. Menopausal Hormone Therapy Labeling To Be Updated, November 2025

Women’s Health Initiative New or Updated

  1. About WHI
  2. Association Between Insomnia, Stress Events, and Other Psychosocial Factors and Incident Atrial Fibrillation In Postmenopausal Women: Insights From the Women’s Health Initiative
  3. BMS TV: Coronary Heart Disease (CHD)
  4. BMS TV: HRT and Breast Cancer: Overall Risks and Benefits
  5. BMS TV: HRT and the Risk of Breast Cancer
  6. Bioidentical Hormones: Are They Safer?
  7. Blood Pressure Control and Glaucoma Risk In Postmenopausal Women: An Analysis From the Women’s Health Initiative
  8. Celebrating the Removal But Cautioning the Removal of All Warnings on HRT [10 November 2025]
  9. Chocolate Consumption In Relation To All-Cause and Cause-Specific Mortality In Women: The Women’s Health Initiative
  10. Circulating Asprosin Concentrations and Body Weight Changes in Postmenopausal Women: Findings from the Women’s Health Initiative
  11. EMAS On-Demand Webinars [European Menopause and Andropause Society] [Multiply Languages]: FDA Decision on MHT Warnings – A Live EMAS Roundtable
  12. FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
  13. FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
  14. FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women
  15. FDA Removes Black Box Warning on HRT- What Does That Mean for the UK
  16. Fact Sheet: FDA Initiates Removal of “Black Box” Warnings From Menopausal Hormone Replacement Therapy Products
  17. Find A Menopause Practitioner [United States and Other]
  18. Find A Practitioner [Australasian Menopause Society i.e. Australia and New Zealand]
  19. Find Your Nearest BMS Menopause Specialist [British Menopause Society]
  20. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
  21. HRT Questions Answered
  22. HRT Types and Doses | Dr Louise Newson
  23. HRT – Types, Doses and Regimens
  24. HRT: Benefits and Risks
  25. HRT: Summary
  26. HRT: The History – HRT Timeline
  27. Here’s What RFK Jr., FDA Got Wrong About Menopausal Hormone Therapy — Ob/Gyns Say We Shouldn’t Return To the Days of Estrogen-for-all, Before WHI Results
  28. Hormone Replacement Therapy (HRT)
  29. Hormone Replacement Therapy (HRT): Benefits and Risks of Hormone Replacement Therapy (HRT)
  30. Hormone Replacement Therapy After the WHI: Clinician’s Evidence Timeline (2002–2025)
  31. Hormone Therapy In Postmenopausal Persons: Primary Prevention of Chronic Conditions
  32. International Menopause Society (IMS) Recommendations and Key Messages on Women’s Midlife Health and Menopause
  33. Infertility and Risk of Heart Failure In the Women’s Health Initiative
  34. Long-Term Changes To Cardiovascular Biomarkers After Hormone Therapy In the Women’s Health Initiative Hormone Therapy Clinical Trials
  35. Longitudinal Patterns of Abdominal Visceral and Subcutaneous Adipose Tissue, Total Body Composition, and Anthropometric Measures In Postmenopausal Women: Results From the Women’s Health Initiative
  36. Menopausal Hormone Therapy Trends Before Versus After 2002: Impact of the Women’s Health Initiative Study Results
  37. Menopausal Hormone Therapy and Cardiovascular Diseases In Women With Vasomotor Symptoms: A Secondary Analysis of the Women’s Health Initiative Randomized Clinical Trials
  38. Menopausal Hormone Therapy and Change In Physical Activity In the Women’s Health Initiative Hormone Therapy Clinical Trials
  39. Menopause
    Women’s Health Initiative
  40. Metabolomic Evaluation of Air Pollution-Related Bone Damage and Potential Mediation In Women’s Health Initiative Participants
  41. News From the WHI Study. WHI Funding Announcement. WHI Funding Update [06 May 2025, 25 April 2025…]
  42. News From the WHI Study. WHI Responds To FDA Removal of Black Box Warning on Hormonal Therapies
  43. Online Events [International Menopause Society]: IMS Partnership Symposia Series – Evaluating High-Risk Patients In Menopause At Risk of Cardiovascular Disease (CVD) [26 November 2026]
  44. Online Events [International Menopause Society]: IMS Partnership Symposia Series – What’s Hot? Options for Treatment of Hot Flushes 2025
  45. Online Events [International Menopause Society]: Past Webinars – 2025: Changing the Paradigm for Earlier Osteoporosis Prevention
  46. Online Events [International Menopause Society]: Sponsored Symposium – Weight, Wellness, and Women At Midlife: Rethinking Obesity In the Menopause Transition
  47. Perimenopause
  48. Perimenopause
  49. Persistent Gap In Menopause Care 20 Years After the WHI: A Population-Based Study of Menopause-Related Symptoms and Their Management
  50. Physical Activity and Stroke Incidence Among Post-Menopausal Women: Insights From the Women’s Health Initiative
  51. Pre-Pandemic Leukocyte Count Is Associated With Severity of Post-Acute Sequelae of SARS-CoV-2 Infection Among Older Women In the Women’s Health Initiative
  52. Psychosocial Stress and Bone Loss Among Postmenopausal Women: Results From the Women’s Health Initiative
  53. Q&A: At 20 Years, WHI Emphasizes Personalized Postmenopausal Care, Shared Decision-Making
  54. Reappraising 21 Years of the WHI Study: Putting the Findings In Context for Clinical Practice
  55. Relationships of Depression and Antidepressant Use With Epigenetic Age Acceleration and All-Cause Mortality Among Postmenopausal Women
  56. The 2023 Practitioner’s Toolkit for Managing Menopause
  57. The Association Between 10-Year Cardiovascular Risk and Fracture Incidence In Postmenopausal Women: A Prospective Analysis From the Women’s Health Initiative
  58. The Menopause Society Statement on Misinformation Surrounding Hormone Therapy
    Women’s Health Initiative
  59. The Role of Topical Vaginal Oestrogen
  60. The Women’s Health Initiative
  61. The Women’s Health Initiative Randomized Trials and Clinical Practice
  62. The Women’s Health Initiative Randomized Trials of Menopausal Hormone Therapy and Breast Cancer: Findings In Context
  63. The Women’s Health Initiative Study and Hormone Therapy – What Have We Learned 10 Years On?
  64. The Women’s Health Initiative Trials: Clinical Messages
  65. ‘Tis But A Scratch: A Critical Review of the Women’s Health Initiative Evidence Associating Menopausal Hormone Therapy With the Risk of Breast Cancer
  66. Updated Labeling for Menopausal Hormone Therapy [10 November 2025]
  67. Videos & Podcasts: Videos – Cardiovascular Disease In Women
  68. Videos & Podcasts: Videos – Preventing Bone Loss At Menopause
  69. Video & Podcast Library: Videos – World Menopause Day 2024: Menopause and Hormone Therapy: Current Perspectives and Controversies
  70. Videos & Podcasts: Videos – Menopause and Hormone Therapy: Current Perspectives and Controversies
  71. Videos and Podcasts: Videos – The Women’s Health Initiative – What Can We Believe?
  72. WHI News and Recent Publications
  73. Whi.org [Women’s Health Initiative]
  74. Women’s Health Initiative (WHI)
  75. Women’s Health Initiative: Recent Publications
  76. World Menopause Day 2023
  77. World Menopause Day 2023: Patient Information Leaflet
  78. World Menopause Day 2024: Leaflet for Women [Multiply Languages]
    Women’s Health Initiative
  79. World Menopause Day 2024: Poster for Women – The 5 Ws of Menopause Hormone
  80. Women’s Health Initiative World Menopause Day 2024: The IMS White Paper: Menopause and MHT In 2024: Addressing the Key Controversies [Multiply Languages]

Sources

Where may I find the Sources quoted?

You may find the Sources quoted at:

Sources

  1. About WHI. Women’s Health Initiative https://www.whi.org/about-whi Accessed: 02 February 2026
  2. About WHI. Women’s Health Initiative https://www.whi.org/about-whi Accessed: 02 February 2026
  3. Women’s Health Initiative (WHI): What Is the Goal of the WHI? National Heart, Lung, and Blood Institute https://www.nhlbi.nih.gov/science/womens-health-initiative-whi Accessed: 02 February 2026
  4. About WHI. Women’s Health Initiative https://www.whi.org/about-whi Accessed: 02 February 2026
  5. Women’s Health Initiative (WHI): What Is the Goal of the WHI? National Heart, Lung, and Blood Institute https://www.nhlbi.nih.gov/science/womens-health-initiative-whi Accessed: 02 February 2026
  6. Women’s Health Initiative (WHI): At A Glance. National Heart, Lung, and Blood Institute https://www.nhlbi.nih.gov/science/womens-health-initiative-whi Accessed: 02 February 2026
  7. Cagannci, A. and Venier, M. The Controversial History of Hormone Replacement Therapy: Abstract. Published Online 18 September 2019 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6780820/ Accessed: 02 February 2026
  8. About WHI. Women’s Health Initiative https://www.whi.org/about-whi Accessed: 02 February 2026
  9. About WHI. Women’s Health Initiative https://www.whi.org/about-whi Accessed: 02 February 2026
  10. Manson, J.A, E. Crandall, C. J., Rossouw, J. E. et al. The Women’s Health Initiative Randomized Trials and Clinical Practice: Abstract – Conclusions and Relevance. 01 May 2024 https://jamanetwork.com/journals/jama/ Accessed: 02 February 2026
  11. Manson, J.A, E. Crandall, C. J., Rossouw, J. E. et al. The Women’s Health Initiative Randomized Trials and Clinical Practice: Abstract – Conclusions and Relevance. 01 May 2024 https://jamanetwork.com/journals/jama/ Accessed: 02 February 2026
  12. News From the WHI Study. WHI Responds To FDA Removal of Black Box Warning on Hormonal Therapies. 11 November 2025. Women’s Health initiative https://www.whi.org/md/news/whi-fda-hrt-warning Accessed: 02 February 2026
  13. Menopause Hormone Therapy: Is It Right for You? Menopause Hormone Therapy Isn’t All good or All Bad. 18 April 2025. Mayo Clinic https://www.mayoclinic.org/diseases-conditions/menopause/in-depth/hormone-therapy/art-20046372 Accessed: 02 February 2026
Topic Last Updated: 31 March 2026 – Topic Last Reviewed: 02 February 2026

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