Written by Dr. Jane Smith, MD
Menopause represents a substantial shift in a woman’s physiological landscape, typically occurring between ages 45 and 55. This natural decline in ovarian hormone production can generate an array of symptoms that significantly affect quality of life: vasomotor instability, urogenital atrophy, insomnia, mood fluctuations, and cognitive disturbances, to name a few. For many, these changes signal not only a biological transition but also an existential one. Hormone replacement therapy (HRT), particularly formulations based on bioidentical hormones, is increasingly considered a targeted approach to managing these effects.
What Are Bioidentical Hormones?
Bioidentical hormones are chemically and molecularly identical to the endogenous hormones produced by the human body. Most commonly, these include estradiol, estriol, and progesterone. Derived from plant sources like yams and soy, bioidentical hormones are compounded or manufactured to mirror the body’s natural hormones.
The differentiation between bioidentical and synthetic hormones often generates confusion. Synthetic hormones, though sometimes derived from similar natural precursors, differ structurally from the hormones they are meant to replicate. This structural variance can influence receptor binding, metabolism, and downstream effects.
Clinical Efficacy of Bioidentical HRT
Research indicates that bioidentical HRT, particularly formulations approved by the FDA such as micronized progesterone and estradiol, are effective in alleviating menopausal symptoms. A 2017 review in “Climacteric” found that women using bioidentical estradiol and progesterone reported significant improvements in vasomotor symptoms, sleep quality, and sexual health.
Moreover, bioidentical hormones, especially when administered transdermally, have been associated with a lower risk of thromboembolic events and stroke compared to oral synthetic preparations. These outcomes are contingent upon appropriate patient selection, dosage individualization, and monitoring—hallmarks of responsible clinical care.
Regulatory Framework and FDA Approval
The FDA has approved a number of hormone therapies that qualify as bioidentical, including estradiol in patches, gels, and tablets, and micronized progesterone in capsule form. These products are subject to stringent regulatory oversight regarding safety, efficacy, and manufacturing standards.
However, a separate category exists for compounded bioidentical hormones. These are prepared in compounding pharmacies using FDA-approved ingredients, tailored to a prescriber’s specifications for an individual patient. It is important to distinguish that while the ingredients are FDA-approved, the final compounded product is not subject to FDA approval. This distinction is often misrepresented or misunderstood in both clinical and popular discourse.
Winona’s Formulary Integrity
Winona offers HRT through both FDA-approved medications and custom-compounded bioidentical formulations. Their oral pills and transdermal patches use bioidentical hormones that are FDA-approved, meeting rigorous standards for consistency and efficacy. Their compounded creams, however, represent a different regulatory pathway.
As per Winona’s official statement:
“Our bioidentical oral pills and transdermal patches are FDA-approved, and our compounded creams are created with FDA-approved ingredients in our compounding pharmacy to match your Winona doctor’s specifications/dosage.”
“Compounding is a practice in which different ingredients found in FDA-approved medicines are combined to create medications that meet the needs of individual patients. Currently, once FDA-approved ingredients are combined, they can no longer be labeled FDA-approved, since the FDA does not regulate compounding. This means that while our creams are not labeled FDA-approved, they are formulated with ingredients from FDA-registered sources.”
This approach underscores a commitment to transparency and patient-specific care. It also reflects an understanding of regulatory boundaries that is essential for health professionals prescribing or recommending these treatments.
Individualization and Patient-Centered Models
Menopause manifests heterogeneously. Some patients experience intense vasomotor symptoms; others may be more troubled by cognitive fog or genitourinary syndrome. The individualization of hormone therapy is therefore central to effective management. Winona employs board-certified physicians who tailor treatment plans to reflect both symptomatology and patient history.
This is where compounded therapy offers potential value: it allows for dosing and combinations not readily available in standardized, FDA-approved products. However, clinical vigilance is critical. Hormone levels must be monitored periodically, and the prescribing professional must remain informed on emerging safety data.
Risks and Controversies
All forms of HRT carry potential risks—breast cancer, cardiovascular events, and gallbladder disease among them. The magnitude of these risks depends on the formulation, route of administration, patient age, and duration of use. Importantly, the “Women’s Health Initiative” trial, often cited in HRT discussions, used conjugated equine estrogens and medroxyprogesterone acetate, not bioidentical hormones.
Subsequent analyses have suggested that bioidentical hormones may have a different risk profile, though long-term data remain incomplete. For compounded hormones, the lack of large-scale, controlled studies remains a limitation. Nevertheless, observational data and small trials have supported their use under medical supervision.
Educational Implications for Healthcare Providers
Providers must be able to distinguish between marketing rhetoric and clinical evidence. The term “bioidentical” is not synonymous with “safer” or “natural,” nor does it imply a lack of risk. Clinicians must guide patients through nuanced discussions, presenting benefits and risks in the context of personal medical history and preferences.
Winona, by providing clear information and medical oversight, serves as a useful model for responsible telehealth-based hormone therapy. Their integration of FDA-approved treatments and well-sourced compounding allows them to meet diverse patient needs while staying within ethical and clinical boundaries.
Conclusion
Menopause is not a disease, but the physiological ramifications of hormonal decline can be profound. Bioidentical hormone replacement therapy offers a meaningful avenue for symptom relief and health optimization, especially when implemented under thoughtful, evidence-based guidance.
Platforms like Winona reflect the future of individualized hormone therapy: rooted in science, regulated when possible, and transparent about the limitations of current regulatory frameworks. Healthcare professionals must continue to advocate for informed, patient-specific approaches while remaining cautious of the limitations that accompany non-standardized formulations.
Author Bio:
Dr. Jane Smith, MD, is a board-certified endocrinologist with over 15 years of experience in women’s health and hormone therapy. She has authored peer-reviewed publications on menopause management and lectures nationally on innovations in hormone replacement. Her practice emphasizes evidence-based, personalized medicine with a focus on midlife health.
References
North American Menopause Society. (2022). The 2022 hormone therapy position statement. Menopause, 29(7), 767–784. https://doi.org/10.1097/GME.0000000000002028
Files, J. A., Ko, M. G., & Pruthi, S. (2011). Bioidentical hormone therapy. Mayo Clinic Proceedings, 86(7), 673–80. https://doi.org/10.4065/mcp.2011.0208
Winona. (n.d.). 5 Ways You Can Benefit from Bioidentical HRT. Retrieved from https://bywinona.com/5-ways-you-can-benefit-from-bioidentical-hrt
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