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How One Controversial Study Shaped 20 Years of Menopause Care

UNITED STATES, JUL 21 – The FDA panel revisits the 2002 Women’s Health Initiative findings amid calls to update hormone therapy guidance after evidence showed breast cancer risk was small and often misreported.

  • That day, the NIH stopped the estrogen-plus-progestin arm of the WHI trial, citing increased blood clots, stroke, heart disease, and breast cancer in women, without attribution.
  • The long-term Women’s Health Initiative trial commenced in 1991 as a $625 million, nine-year study evaluating conjugated equine estrogen plus progestin and conjugated equine estrogen alone regimens.
  • After the WHI findings, up to 91,000 women died prematurely from conditions HRT might have prevented, study published in 2013, highlighting the impact on mortality.
  • Amid growing research momentum, the FDA convened an expert panel and experts urged removal of the black box warning on vaginal estrogen, supporting policy updates.
  • Amid growing advocacy, experts now argue that recent data shows benefits of HRT outweigh risks for most women, prompting a shift in menopause care.
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InsideNoVA.com broke the news in on Monday, July 21, 2025.
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