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Lynchburg Journal of Medical Science

Specialty

Women's Health

Abstract

This narrative review compares the safety, efficacy, and clinical utility of FDA-approved

versus compounded bioidentical hormone replacement therapies for women in

menopause. A comprehensive literature review was conducted using PubMed for

studies published between 2016 and 2026, with search terms including “bioidentical

hormone replacement therapy,” “compounded hormone replacement therapy,”

“menopause,” “menopausal,” “vasomotor,” “estradiol,” “progesterone,” and

“testosterone,” alongside an analysis of major medical societies' guidelines and leading

menopause telehealth platforms. The findings demonstrate that FDA-approved

bioidentical hormone therapies offer superior pharmacokinetic consistency, rigorous

regulatory oversight, and robust clinical evidence compared to compounded

alternatives, which lack standardized testing and regulatory oversight for routine

clinical recommendation. Notably, this review highlights the landmark November 2025

FDA decision to remove black box warnings from approved bioidentical hormones,

fundamentally shifting the clinical risk-benefit assessment. Ultimately, FDA-approved

bioidentical hormone replacement provides a safer, evidence-based approach to

menopause management. These findings have direct implications for physician

associates and other practicing providers in primary care and women’s health, as they

equip providers with the critical data needed to confidently counsel patients and

counter marketing narratives surrounding compounded strategies.

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