Hormone Replacement Therapy

Breaking Down the Black Box: Understanding Perimenopause, Menopause, and Hormone Replacement Therapy (HRT)

On November 10, 2025 the FDA announced that it is removing the so–called “black box” warning from more than 20 hormone therapies for perimenopause and menopause — a landmark change after decades of caution-laden messaging.

The “black box” warning was intended to signal the highest level of FDA caution about potentially life-threatening risk. The removal reflects a shift toward an evidence-based approach, given more recent data and statistical analyses. The result is giving women and their physicians more tools in their toolbox for navigating side effects associated with perimenopause and menopause.  What this means: the therapies once shrouded in fear are now being reframed as viable options when used appropriately.  

To cut through the confusion, we spoke with Dr. Erin McDonald to break down what’s happening in your body during this stage of life, when hormone therapy might be appropriate, and how lifestyle choices can support overall wellness. Whether you’re just noticing irregular cycles or have already transitioned into menopause, understanding your options can empower you to feel your best. Many women struggle to know what’s “normal” and how to manage symptoms effectively. 

Perimenopause vs. Menopause: Key Differences, Age Ranges, and Hormonal Changes 

Many women experience hormonal changes differently, and understanding the distinction between perimenopause and menopause is essential for navigating this stage of life. 

Perimenopause is the transitional period leading up to menopause, usually starting in a woman’s early-to-mid 40s. During these years, estrogen and progesterone levels fluctuate unpredictably, causing irregular menstrual cycles, mood changes, and other symptoms. Perimenopause symptoms can last anywhere from a single year to a decade or more; it’s highly individual, and the severity of symptoms varies widely. 

Although the age of menopause is highly variable, it is defined as the point when a woman has gone 12 consecutive months without a menstrual period. In the United States, the average age of menopause is 51. By this stage, levels of estrogen and progesterone are consistently low unless a woman uses hormone therapy. 

Perimenopause and Menopause Symptoms: Hot Flashes, Sleep Issues, and Mood Changes 

While irregular menstrual cycles are the most well-known sign of perimenopause, hormonal fluctuations can impact nearly every aspect of daily life. Dr. Erin McDonald explains, “The hormonal swings in perimenopause aren’t just about missing periods, they affect mood, energy, and even how your body handles sleep and recovery. It’s very individual, and that’s why personalized care is so important.” 

Common symptoms include hot flashes, night sweats, and disrupted sleep, which can leave women feeling fatigued and irritable. Mood changes such as increased anxiety, irritability, or feelings of being “not yourself” are also frequent. Musculoskeletal issues like joint pain or loss of lean muscle mass, and sexual health concerns including vaginal dryness, pain with intercourse, and urinary changes, can also appear. Understanding these symptoms and recognizing which are typical versus signs of other health issues, is a critical step in managing the transition effectively. Before we jump into treating some of these symptoms, let’s take a glimpse of the history of hormone therapy.  

Hormone Therapy History: From Premarin to Modern HRT 

Dr. Erin McDonald emphasizes: “A lot of the fear around HRT comes from outdated studies that don’t reflect the women we treat today. When started at the right time, for the right patient, hormone therapy can be safe and incredibly effective.” 

Brief History of Hormone Replacement Therapy 

• 1950s: HRT enters the scene with Premarin, an estrogen therapy for menopausal symptoms. 

• 1970s–80s: Combination HRT (estrogen + synthetic progestins like MPA) becomes widely used for symptom relief and bone health. Progestins are found to offset risk of endometrial cancer seen in women who use estrogen and have not had a hysterectomy. 

• 1990s: The Women’s Health Initiative (WHI) study links HRT to a slight increase in breast cancer risk, triggering a sharp decline in prescriptions. 

• Early 2000s: The progesterone/estrogen arm of the WHI study was stopped in 2002, leading to a significant drop in the use of combined HRT. Media coverage causes confusion and fear, leaving many women without symptom management options. 

• Post WHI Reevaluation: 

• Initial WHI study primarily involved women aged 60–70, not the typical age for starting HRT. 

• The original study used synthetic hormones, unlike today’s bioidentical hormones, which are the same as natural estradiol and progesterone, that is made by ovaries. 

• More recent studies and evaluations of subsets of the original WHI data support that HRT can be highly beneficial for many women if started in perimenopause or within 10 years of their last menstrual period.  

• 2025- Current Understanding: FDA removes the black box warning based on current evidence. 

Modern research, confirmed by the recent removal of the black-box warning, now recognizes that, when appropriately prescribed, HRT can relieve a variety of symptoms and side effects. By combining HRT with lifestyle strategies such as regular strength training, balanced nutrition, consistent sleep, and stress management, women can maximize both immediate symptom relief and long-term health benefits. 

HRT Benefits at a Glance

Lifestyle Changes: Sleep, Exercise, Nutrition, and Stress Management 

Dr. Erin McDonald emphasizes, “For women in their 30s, the habits you build now lay the foundation for how you experience perimenopause and menopause. Prioritizing sleep, regular exercise, balanced nutrition, and stress management isn’t just about symptom prevention; it’s about long-term health and vitality.” 

By adopting these lifestyle strategies early, women can better prepare for hormonal changes and support overall well-being, complementing treatments like HRT when appropriate. 

Sleep: 

• Aim for 7–8 hours per night 

• Maintain a consistent bedtime routine 

• Good sleep helps reduce fatigue, mood swings, and hot flashes
   

Exercise: 

• Strength training 2–3 times per week preserves muscle mass and supports bone density 

• Daily movement, like walking or biking, boosts metabolism and energy
   

Nutrition: 

• Focus on a nutrient-dense, whole foods diet 

• Minimize processed foods, alcohol, and caffeine to help manage hot flashes and inflammation  

• Maintain a healthy body weight to reduce symptom severity
   

Stress Management: 

• Incorporate mindfulness, meditation, or breathing exercises 

• Use social connections, exercise, and hobbies as stress-relief tools 

• Managing stress helps prevent symptom exacerbation 

By adopting these strategies early, women can better prepare for hormonal changes and support overall well-being, complementing treatments like HRT when appropriate. 

The Priority Approach 

Hormone therapy doesn’t have to be confusing or intimidating. At Priority, our physicians are here to help you navigate your options and create a plan that fits your unique needs, lifestyle, and health goals. This may include systemic or vaginal hormones, lifestyle strategies like sleep, exercise, nutrition, and stress management, as well as ongoing monitoring to adjust your plan as your needs change. It’s important to note that not all women are good candidates for HRT. That said, there are excellent non-hormonal treatment options to help women who might not benefit from HRT. Always discuss these options with your physician directly. 

Dr. Erin McDonald emphasizes, “A conversation about hormone therapy should start with education and transparency. When guided by a knowledgeable clinician, hormone therapy can be a safe, effective way to improve your quality of life.”