What Happens When Women ACTUALLY Get State-of-the-Art Medical Care in Menopause?

Readers of The Vajenda have been incredibly helpful at filling studies that I have promoted, and so I am hoping we can help recruit and quickly fill this new, important study.

Menopause is not just a reproductive event. It is a cardiometabolic transition that is associated with a variety of changes that increase health risks:

• Fat distribution shifts, with more accumulation around the abdomen and internal organs, even without significant weight gain

• Cholesterol patterns change, including increases in LDL cholesterol and apolipoprotein B

• Blood vessels become stiffer and blood pressure may rise

• Sleep can become disrupted

• Decreased physical activity can affect muscle mass

It is tempting to say, “It’s all estrogen,” but biology is much more complicated than that.

Some of the most rapid metabolic changes occur during late perimenopause, when estradiol levels may still fluctuate dramatically and may even be high, so it is hard to shoulder all of the blame on low estrogen. Other possible contributors include changes in the FSH (follicle stimulating hormone), shifts in the balance between androgens and estrogens, sleep disruption, changes in energy expenditure, and loss of lean muscle mass due to aging and inactivity.

The problem is that many women do not realize these changes are happening as there has been very little public awareness that the menopause transition is a time of accelerated risk, and many women do not get the recommended medical assessments and care. A group of researchers wondered, what would happen if women actually received state-of-the-art, guideline-based, truly comprehensive medical care during this transition? What if their blood pressure and cholesterol were assessed and treated according to current guidelines? What if their activity and sleep were monitored, and then evidence-based recommendations made based on that data? What if menopause hormone therapy or non hormone therapy were prescribed when indicated for symptoms?

Could comprehensive care during this window minimize the health impact of the menopause transition?

“Focusing on the Menopausal Transition to Improve Mid-Life Women’s Health,” is a two-year intervention study enrolling approximately 200 women that hopes to answer this question. This is the study Dr. Nanette Santoro mentioned recently during our Substack live. Here is the page at ClinicalTrials.gov

What is interesting is that the investigators are not assuming there is a single biological issue as the root cause, nor that estrogen is necessarily the answer. They are treating menopause as a window for preventive medicine, and asking, what happens when women receive the level of medical care they should have been receiving all along? They are also recognizing that one major problem is not that we lack tools, but that we have not consistently applied the tools we already have.

Participants will have:

• An in-person evaluation

• Assessment of menopause symptoms

• Laboratory testing

• Cardiovascular assessments including vascular function testing

• Monitoring of activity and sleep with a Fitbit

• Regular telehealth follow up

Based on each participant’s health profile, the investigators will recommend individualized, evidence-based care, which may include some or all of the following: lifestyle modifications; treatment of elevated blood pressure and cholesterol; weight management strategies, when appropriate (including metformin and semaglutide); and menopause symptom treatment including menopausal hormone therapy or fezolinetant for approved indications (hot flashes and night sweats).

This study isn’t just about tracking symptoms, sleep, or physical activity. It is also about actual medical care, because it’s about closing the gap between what we know and the care that women receive. Changes in health over two years will be evaluated and compared with baseline, including changes in epigenetic aging measures and vascular function.

The current online discourse, which has bled into the clinical care many women receive, is that menopause care is synonymous with menopause hormone therapy. In addition, assessment and treatment of cardiometabolic risk factors in women, including high blood pressure, elevated lipids, and diabetes risk, continues to fall short of guideline recommendations. Women are less likely than men to receive preventive therapies such as statins when they meet the criteria for treatment, and frustratingly, there is even an online discourse from some menopause influencers claiming that statins don’t work for women (They do work! You can read about the supporting evidence here).

This study is actually asking a broader and more interesting question that is relevant to women right now. What if we paid attention to women’s health risks when they begin to accelerate and used ALL of the evidence-based tools we have at our disposal?

There will be three in-person visits and monthly telehealth visits. The study will ultimately recruit at three sites: the University of Colorado (Denver/Aurora, CO), the University of North Carolina (Chapel Hill, NC), and Virginia Commonwealth University (Richmond, VA).

Inclusion Criteria:

• Aged 45-55

• In the late menopausal transition, defined as at least 60 days between periods but less than 365 days without a period

• No current use of hormone therapy or hormonal contraception

• Presence of a uterus and at least one ovary in order to track menstrual patterns

• Have a smartphone and broadband access adequate to accept telehealth appointments

I have contact information for two of the recruiting sites:

University of Colorado: Carrie Hsu, carrie.hsu@cuanschutz.edu

University of North Carolina: Makayla Sweeney, REI_Research@med.unc.edu

The Vajenda community has helped fill important studies before. Let’s do it again and help advance better care for women.