Perimenopause and menopause mark a significant physiological transition. During this phase, multiple systems in the body are affected, including sleep, mood, metabolism, skin health, bone density, and sexual well-being. At Beleza Clinic in Columbia, MD, we recognize that menopause care has advanced considerably in recent years. As a result, updated research, regulatory changes, and new FDA-approved therapies are reshaping how clinicians approach treatment. Today, care is more individualized, evidence-based, and patient-centered.

In this article, we explain what BHRT (Bioidentical Hormone Replacement Therapy) is. We also review recent regulatory updates and explore how new hormonal and non-hormonal therapies are expanding safe treatment options for women in perimenopause and menopause.

What Is BHRT and How Does It Work?

BHRT uses hormones that are chemically identical to those naturally produced by the human body. Most commonly, these include estradiol and progesterone. These therapies are available as FDA-approved medications or as compounded formulations prepared by specialized pharmacies.

However, it is essential to understand the clinical distinction between these options. FDA-approved bioidentical hormones undergo rigorous testing for safety, efficacy, and quality. In contrast, compounded therapies often lack large-scale clinical trial data and standardized dosing. For this reason, leading medical organizations consistently recommend evidence-based prescribing that prioritizes patient safety.

BHRT and Evidence-Based Menopause Care

In the past, menopause treatment often followed generalized recommendations. Today, however, clinical care has shifted toward personalized medicine. Physicians now assess age, symptom severity, medical history, and individual health goals before initiating therapy.

When appropriately prescribed and closely monitored, BHRT may help alleviate hot flashes, improve sleep quality, stabilize mood, and support bone health. In addition, many women report improvements in overall quality of life during the menopausal transition.

FDA Regulatory Updates in Menopause Hormone Therapy

In late 2025, the FDA, working with the U.S. Department of Health and Human Services, announced plans to revise outdated “black box” warnings on certain hormone therapies. These warnings were originally based on early interpretations of large population studies. Importantly, those studies did not adequately account for hormone type, dosage, delivery method, or patient age.

More recent research has clarified that hormone therapy risks vary significantly. Specifically, outcomes depend on:

• Patient age

• Time since menopause onset

• Type of estrogen or progesterone prescribed

• Route of administration, such as oral or transdermal

As a result, current regulatory guidance supports a more nuanced and individualized approach to menopause care.

Non-Hormonal Menopause Treatments: Lynkuet® (Elinzanetant)

Another major advancement in menopause care is the FDA approval of Lynkuet® (elinzanetant). This non-hormonal medication treats moderate to severe hot flashes.

Elinzanetant works by blocking neurokinin receptors in the brain that regulate body temperature. Clinical trials have shown significant reductions in vasomotor symptoms. Additionally, many patients experience improved sleep quality.

Therefore, this therapy offers an important alternative for women who cannot use hormone therapy or prefer non-hormonal options.

Advances in Female Sexual Health During Menopause

Historically, female sexual health has received limited clinical attention. Recently, however, progress has accelerated. The FDA expanded approval of Addyi® (flibanserin) for certain postmenopausal women with hypoactive sexual desire disorder (HSDD).

Previously approved only for premenopausal women, this expanded indication recognizes that low libido during menopause is a valid medical concern. Nevertheless, appropriate screening and counseling remain essential, as flibanserin has specific contraindications and requires careful clinical oversight.

Personalized Menopause Care at Beleza Clinic in Columbia, MD

These scientific and regulatory advancements directly inform how care is delivered at Beleza Clinic in Columbia, MD. Our clinical approach emphasizes safety, personalization, and long-term health.

We focus on:

1. Individualized risk–benefit assessment based on each patient’s profile

2. Preference for FDA-approved therapies supported by clinical evidence

3. Incorporation of non-hormonal treatments when appropriate

4. Whole-body evaluation, including metabolic, bone, skin, and sexual health

5. Ongoing monitoring, with regular follow-ups and lab assessments

Evidence-Based Progress, Explained Clearly

Modern menopause care continues to move toward precision medicine. Treatments are now tailored, risks are better contextualized, and patients are empowered with accurate information. Consequently, regulatory updates and new therapies reflect a broader commitment to advancing women’s health.