Bioidentical Hormone Replacement Therapy (BHRT): What it is, who benefits, and what the FDA says now

David S. Klein, MD FACA FACPM
Nov 12
4 min read

Bio-identical HRT and skin effects — The skin is the first organ system to reflect the aging of the hormonal system. Wrinkles, sagging appear early.

If you’ve been struggling with hot flashes, night sweats, sleep disruption, brain fog, or painful intimacy, hormone changes are a likely driver. Bioidentical hormone replacement therapy (BHRT) uses hormones with the same molecular structure your body makes—most commonly 17β-estradiol, testosterone and micronized progesterone—to restore balance and relieve symptoms. Multiple national societies agree that appropriately prescribed hormone therapy is the most effective treatment for vasomotor symptoms and genitourinary syndrome of menopause, and it helps prevent bone loss and fractures. The optimal formulation, dose, and route are individualized—and that is precisely where a careful, physician-guided plan at Stages of Life Medical Institute can make a meaningful difference. PubMed+2LWW

Journals+2

The latest FDA context (2025)

In November 2025 the FDA moved to remove the long-standing boxed warning from labels of many estrogen-containing menopause therapies, reflecting contemporary evidence and encouraging individualized risk–benefit discussions. Professional societies, including ACOG, welcomed the change and simultaneously reiterated that compounded estrogen products are not backed by FDA for safety or efficacy. Separately, the FDA continues to emphasize that compounded drugs are not FDA-approved and that the agency does not have evidence they are safer or more effective than approved therapies. U.S. Food and Drug Administration+3AP News+3ACOG+3

Benefits patients actually feel

Rapid symptom relief. Estradiol—especially transdermal—remains the most effective therapy for hot flashes and night sweats; many patients report better sleep and cognition once nocturnal symptoms abate. Micronized progesterone can improve sleep quality for some. PubMed
Genitourinary health. Local vaginal estrogen (very low systemic absorption) improves dryness, dyspareunia, and recurrent UTI risk by restoring urogenital tissues. PubMed
Bone protection. Standard-dose HT prevents bone loss and reduces fracture risk; timing, dose, and delivery route matter. PubMed
Cardiometabolic nuance. Starting within 10 years of menopause and before age 60 is associated with a more favorable balance of benefits/risks; transdermal routes and lower doses may lower VTE and stroke risk compared with oral forms. Australasian Menopause Society

What about pellets and other compounded options?

I am not a fan of using Pellets to provide HRT. Your body needs the levels of these hormones to vary on a daily basis, and when you use pellet injection, the result is constant levels that are entirely unnatural. My preference is to use transdermal creams, applied on a daily basis, timed to correspond to the natural diurnal changes that the body requires.

On the other hand, Pellets are a compounded delivery system (not FDA-approved) implanted subcutaneously. Because the dose cannot be adjusted or removed easily and quality can vary, professional guidance cautions against routine pellet use—particularly for testosterone in women—when FDA-approved alternatives exist. Reported adverse effects (e.g., mood changes, acne, abnormal bleeding) appear more frequent with pellets than with approved products in some observational datasets. ACOG+1

How Stages of Life approaches BHRT

Evidence-guided evaluation. We start with a detailed history, risk assessment, and labs only when they’ll change management.
Prefer FDA-approved bioidentical options (estradiol, micronized progesterone) tailored to your goals, risk profile, and preferences (patch, gel, ring, oral, or local therapy). The ObG Project
Thoughtful monitoring. We track symptom response, side effects, and dose—not just lab numbers—to keep you squarely in the therapeutic sweet spot.
Compounding only when indicated. If an allergy, intolerance, or unique dose/form is required, we use reputable compounding partners and counsel transparently on benefits and limits. The FDA and multiple societies note that evidence for routine compounded BHRT is limited. U.S. Food and Drug Administration+1

Safety, risks, and personalization

Hormone therapy isn’t for everyone. Contraindications and relative risks must be weighed (e.g., prior estrogen-sensitive cancer, active thromboembolic disease, uncontrolled hypertension). For most healthy, symptomatic women within 10 years of menopause onset and under 60, the benefits often outweigh risks when therapy is individualized. The 2025 label update underscores the importance of nuanced, patient-specific decisions rather than blanket fear from outdated warnings. Australasian Menopause Society+1

Bottom line

Bioidentical hormone therapy—using FDA-approved formulations whenever possible—can safely and powerfully improve quality of life, intimacy, sleep, and bone health when matched to the right patient, at the right dose and route, with competent follow-up. If you’re ready to feel like yourself again, the Stages of Life team will meet you where you are and guide you forward, step by step.

References

Faubion SS, et al. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022;29(7):767-794. doi:10.1097/GME.0000000000002028. PubMed
The Menopause Society. 2022 Hormone Therapy Position Statement—Press and summary materials. 2022. The Menopause Society+1
FDA. Menopause—Are compounded “bioidentical hormones” safer or more effective? Updated Dec 14, 2023. U.S. Food and Drug Administration
FDA. Compounding and the FDA: Questions and Answers. Updated Sept 16, 2025. U.S. Food and Drug Administration
FDA Expert Panel on Menopause and Hormone Replacement Therapy (public meeting). July 17, 2025. U.S. Food and Drug Administration
Associated Press. FDA removes boxed warning from hormone-based menopause drugs. Nov 2025. AP News
ACOG. President says label change on estrogen will increase access to hormone therapy. Nov 2025. ACOG
ACOG Clinical Consensus No. 6: Compounded bioidentical menopausal hormone therapy. Obstet Gynecol. 2023. (and web version). ACOG+1
Stuenkel CA, et al. Compounded bioidentical hormone therapy. Climacteric. 2021;24(4):389-397. PubMed
National Academies of Sciences, Engineering, and Medicine. The Clinical Utility of Compounded Bioidentical Hormone Therapy. Washington, DC: NAP; 2020. doi:10.17226/25791. National Academies Press
Endocrine Society. Position Statement: Compounded “Bioidentical” Hormone Therapy. 2019. Endocrine Society+1
Alabama Board of Medical Examiners summary of ACOG Clinical Consensus (2023). Alabama Medical Board
The OB-G Project. NAMS HT Position Statement summary and FDA-approved formulations list (2022–2024). The ObG Project+1
Contemporary OB/GYN. Safety and efficacy of non-FDA-approved menopause therapies (pellet adverse effects summary). 2023. Contemporary OB/GYN
Let’s Talk Menopause. NAMS 2022 HT highlights for patients (benefit/risk framing). 2022.