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Early Estrogen Use and the FDA Updates — Big News

Nov 11, 2025

A New Chapter for Women’s Hormone Therapy

There’s been a wave of encouraging news for women’s health recently — both from new research and the FDA. A large real-world study found that starting estrogen therapy earlier in menopause may lower the risk of several major diseases. And in a historic move, the FDA announced it will remove the long-standing “black box” warning from most hormone replacement therapy (HRT) products.

Together, these developments are reshaping the conversation about menopause and empowering women to make more informed, individualized decisions about their care.

What the New Study Found

A recent study analyzed data from millions of women and found that starting estrogen therapy during the perimenopausal phase — around the time periods become irregular or within the first years after menopause — was linked to a striking reduction in several health risks.

Women who began therapy early and continued for at least ten years had:

  • Roughly 60% lower odds of developing breast cancer, heart attack, and stroke compared to women who started later or never used estrogen.

  • A stronger protective effect when therapy was started close to menopause, suggesting that timing plays a critical role in the benefits of hormone therapy.

Women who began estrogen many years after menopause also still saw modest benefits, but the data suggested a slightly higher stroke risk in this group — reinforcing that early intervention may matter most.

These findings support what experts have called the “timing hypothesis”: that the body responds differently to estrogen depending on when therapy begins. The earlier it’s started (for the right patient), the more likely it supports overall health and symptom control with fewer risks.

The FDA Removes the Black Box Warning

For more than 20 years, most hormone therapy products carried a “black box” warning — the strongest caution the FDA uses — about potential risks for breast cancer, heart attack, stroke, and dementia. Those warnings were largely based on older data from the early 2000s, when hormone therapy was prescribed to women well past menopause using higher-dose, synthetic formulations.

This year, the FDA officially announced it will remove the black box warning from most menopausal hormone products. The decision reflects decades of new evidence showing that risks are significantly lower when HRT is started earlier in the menopausal transition. This decision also includes using modern formulations and personalized dosing.

Here’s what this change means for women:

  • Reduced stigma: The removal of the warning acknowledges that hormone therapy can be safe and beneficial for many women.

  • Updated understanding: The FDA now recognizes that the original warnings overstated risks for younger, women seeking relief from menopausal symptoms.

  • More access and reassurance: Many women and clinicians were hesitant to consider HRT because of the warning. Its removal will hopefully open the door to more nuanced, evidence-based care.

  • Important exception: The FDA will continue to warn about endometrial cancer risk in women who take estrogen alone and still have a uterus — which is why pairing estrogen with progesterone is essential in these cases.

What This Means for You

At Flow Wellness, we view this as a turning point in women’s health — and an opportunity to revisit long-held assumptions about menopause care.

If you’re entering your 40s or 50s and beginning to notice symptoms such as hot flashes, night sweats, mood changes, sleep disruption, or fatigue, this may be the right time to start a conversation about hormone therapy.

Here’s what we discuss with our patients:

  • Timing: Starting HRT within 10 years of menopause onset (or before age 60) appears to provide the most benefit and the least risk.

  • Personalization: The right therapy depends on your health history, cardiovascular profile, breast and uterine health, and overall wellness goals.

  • Formulation & route: Modern options include lower doses and bioidentical hormones— all designed for more stable absorption and a lower side-effect profile.

  • Monitoring: Regular follow-up visits and lab work ensure your therapy remains safe and effective as your body and needs change.

  • Whole-body wellness: Hormone balance affects metabolism, mood, bone strength, and even brain health. We help you strike a balance that feels good to your brain, body, and goals.

A Modern Approach to Menopause

The message is clear: hormone therapy, when started at the right time and tailored to the individual, can do far more than ease hot flashes. It may help protect long-term health — supporting the heart, brain, bones, and overall vitality. The FDA’s updated stance and new research reinforce what we’ve long believed at Flow Wellness: that menopause is not the end of youth or energy. It’s a stage of life that deserves proactive, careful, science-based care.

Ready to Feel Like Yourself Again?

If you’re curious about whether hormone therapy is right for you, our medical providers can help you explore your options. We specialize in personalized care that integrates medical science with whole-body wellness.

Schedule your consultation today at Flow Wellness in Bend or Seattle to discuss your symptoms, review lab work, and develop a plan that restores balance and helps you feel your best — inside and out.

Learn More:

Track Your Progress Like Never Before with a Body Composition Scan

Why So Many Women Aren’t Getting Menopause Treatment (and Why That Needs to Change)

Real Reviews of Bioidentical Hormone Replacement Therapy

Disclaimer: This blog post is for informational purposes only and should not be considered medical advice. Always consult with a healthcare provider for personalized medical advice.

The Flow Wellness Difference

IV Therapy | Peptide Therapy & Prescription Supplement | Medical Weight Loss | Hormone Replacement | Ketamine Therapy

Clinic locations in Bend, Oregon (Old Mill) & Seattle, Washington (South Lake Union). Telehealth in California, Oregon, & Washington

GLP-1 Medical Weight Loss & Microdosing

Our medical weight loss & microdosing programs are designed to deliver safe, sustainable results. We combine prescription medications, nutritional guidance, lifestyle coaching, and ongoing medical monitoring to help you lose weight, improve metabolic health, and maintain your results long-term.

Hormone Replacement Therapy (HRT)

We offer hormone optimization for men and women to address fatigue, mood changes, weight gain, and other symptoms of hormonal imbalance. Our bioidentical hormone replacement programs are personalized to restore optimal levels and support overall vitality.

Peptide Therapy & Prescription Supplements

Peptides are short chains of amino acids that play a vital role in cellular function and repair. At Flow Wellness, we offer personalized peptide protocols to support athletic performance, muscle recovery, and cognitive performance. Prescription supplements available for enhanced energy, hair & skin rejuvenation, and sexual health. All treatments are medically supervised for safety and results.

Ketamine Therapy for Mental Health

Flow Wellness provides IV & oral ketamine treatments in a safe, controlled, and supportive environment. This innovative treatment has shown promise for individuals struggling with depression, anxiety, PTSD, and other mental health challenges—especially when traditional therapies have been ineffective. IV treatments available at our Bend, Oregon clinic.

IV Therapy in Bend, Oregon

Our customized IV infusions deliver rapid hydration and essential nutrients directly into your bloodstream for maximum absorption. Whether you’re looking to boost your immune system, recover from illness, enhance athletic performance, or simply feel more energized, our IV therapy options are designed to meet your specific needs.

Why patients love working with us:

  • Transparent pricing and no guesswork
  • Fast shipping or in-clinic pickup
  • Friendly, experienced medical providers who really care

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