By Dr. David LaMond, Medical Director, Blue Sky MD
If you’re a woman navigating menopause, chances are you’ve heard conflicting messages about hormone replacement therapy (HRT)—especially estrogen. For years, women have been told to avoid it at all costs, based largely on one study from 2002 that caused widespread confusion, fear, and—unfortunately—suffering.
That may finally be changing.
On July 17, 2025, the FDA hosted a historic roundtable with over 400 experts, including clinicians, researchers, and patients, to reassess the safety and benefits of HRT. I want to share what came out of this important meeting and how it aligns with what we’ve been practicing for years at Blue Sky MD.
The 2002 WHI Study: A Misinformed Legacy
For decades, the Women’s Health Initiative (WHI) study has shaped public and medical opinion about estrogen therapy. But there’s a catch: that study was based on women who were, on average, 63 years old, many more than a decade past menopause, and it used hormone formulations that are rarely used today.
Newer research tells a different story.
When to Start Estrogen for Menopause: The “Critical Window”
Experts now agree that when estrogen is started within 10 years of menopause, it can offer powerful benefits:
1. Heart Health:
Estrogen can reduce the risk of heart disease by up to 50%, especially when delivered through the skin (transdermal).
2. Bone Strength:
It prevents bone loss and significantly lowers the risk of fractures.
3. Brain Function:
Early estrogen use may protect against cognitive decline and Alzheimer’s disease.
4. Emotional Well-being:
For many women, it restores sleep, energy, mood, and libido, often after years of suffering.
“Estrogen, when timed correctly, is one of the most powerful disease prevention tools we have.”
— Dr. Marty Makary, Johns Hopkins surgeon and FDA panelist
The Black Box Warning Problem
Today’s estrogen products still carry a black box warning, the FDA’s strongest caution label. But that label is based on outdated drugs, older women, and oral forms of estrogen—not on safer, modern therapies like transdermal estradiol or vaginal estrogen.
At the roundtable, doctors called on the FDA to:
- Update these warnings to reflect current science.
- Differentiate between delivery methods (patch, gel, vaginal tablet, etc.).
- Help women and providers make informed, personalized choices.
Real Women, Real Stories
Some of the most moving moments came from women who shared their experiences of being misdiagnosed, dismissed, or treated with antidepressants instead of hormones. Many said they felt like they were “losing their minds”—until they finally received proper care.
Their stories are heartbreaking, and far too common. But they also highlight what’s possible when women are heard, believed, and given the right treatment.
What This Roundtable Means for You
At Blue Sky MD, we’ve always believed in evidence-based, individualized menopause care. We use bioidentical hormones, prioritize non-oral delivery methods, and monitor each patient’s progress with care and compassion.
The FDA’s roundtable confirms what we’ve seen in practice for years: estrogen, when used properly, is not only safe—it can be life-changing.
If you’ve been told “you just have to deal with it,” or if you’ve tried everything except HRT, I encourage you to reach out. There’s never been a better time to explore safe, effective options for reclaiming your health during menopause and beyond.
Next Steps
The FDA has opened a public comment period, and regulatory changes may be coming soon. We’ll keep you informed every step of the way.
In the meantime, we’re here to help. Schedule a consultation and let’s talk about whether hormone therapy is right for you.
You can watch the full FDA roundtable on Estrogen here:
https://www.youtube.com/watch?v=_2ZRlOivC5M
Estrogen therapy can be safe for many women when prescribed and monitored by a qualified healthcare provider. The safety depends on several factors like your age, health history, and timing relative to menopause. It’s generally considered safest for women within 10 years of menopause onset or under age 60 who don’t have contraindications like a history of blood clots, stroke, or certain cancers. Your doctor will help you evaluate your personal risk factors, family history, and current health status to determine if estrogen therapy is appropriate for you.
The FDA didn’t exactly “reverse” estrogen, but they did change their recommendations and remove the “black box warning”. The FDA now recognizes that hormone therapy can be beneficial for younger, recently menopausal women when used appropriately, leading to more nuanced guidelines rather than blanket restrictions.
Hormone Replacement Therapy can be administered in various forms, such as pills, skin patches, gels, or creams. It is often prescribed to men and women who are experiencing uncomfortable symptoms of aging, but it can also be used for other conditions such as osteoporosis.
Hormone therapy is highly effective for treating vasomotor symptoms like hot flashes and night sweats, often reducing them by 80-90%. It also helps with vaginal dryness, painful intercourse, mood swings, sleep disturbances, and brain fog. Additional benefits may include improved bone density, reduced joint aches, better skin elasticity, and protection against heart disease when started early in menopause. Hormone therapy can also help with urinary symptoms like frequency and urgency. The treatment is most effective for symptoms directly related to declining estrogen levels during menopause.
Hormone Replacement Therapy can be administered in various forms, such as pills, skin patches, gels, or creams. It is often prescribed to men and women who are experiencing uncomfortable symptoms of aging, but it can also be used for other conditions such as osteoporosis.
