For most patients, yes, and the regulatory picture has improved. In November 2025 the FDA asked manufacturers to remove the long-standing boxed warning from menopausal hormone therapy after a full review of the evidence, and in February 2026 it approved the first updated labels. The FDA also pointed to randomized data showing lower all-cause mortality and fewer fractures among women who begin systemic hormone therapy within ten years of menopause. Suitability is still determined individually at a medical consultation.

What Is Bioidentical Hormone Replacement Therapy (BHRT), and How Does It Compare to Synthetic Hormones?

Q: What are the benefits of BHRT?

For women, relief from hot flashes, night sweats and disrupted sleep, relief from vaginal dryness and urinary symptoms, and support for bone density. For men with low testosterone, improved energy, libido, muscle mass and body composition. Many patients also report clearer thinking and steadier mood.

Q: Are bioidentical hormones FDA-approved?

Many are. Estradiol patches, gels, sprays and rings and micronized progesterone capsules are all FDA-approved bioidentical products. Compounded preparations such as hormone pellets are prepared for the individual patient rather than mass-produced, so they are dosed and verified patient by patient. Dr. Temkin checks hormone levels before every pellet insertion and again partway through the cycle.

Bioidentical hormone replacement therapy (BHRT) uses hormones that are chemically identical to the ones your body already makes — mainly estradiol, progesterone and testosterone. “Bioidentical” refers to the molecule itself: it has the same structure as the hormone your own body produces, so it binds to the same receptors and behaves the same way once it is in your system. That is the whole idea behind it. Rather than substituting a hormone-like drug, BHRT replaces what has declined with the same molecule your body was making all along.

BHRT comes in several forms, and most of them are FDA-approved products you can pick up at any pharmacy: estradiol patches, gels, sprays and vaginal rings, and micronized progesterone capsules. Others, such as hormone pellets, are prepared for the individual patient by a compounding pharmacy. Because bioidentical hormones match your body’s own chemistry, your physician can choose the exact molecule and the exact delivery method that suits your symptoms, your labs and your life — rather than fitting you to whatever a single product happens to offer.

What Are the Benefits of BHRT?

For women, BHRT is most often used to address the symptoms of perimenopause and menopause. For men, it restores testosterone when levels have fallen. Patients commonly see:

Relief from hot flashes and night sweats
Better, more consistent sleep
Relief from vaginal dryness and urinary symptoms
Support for bone density and long-term bone strength (women)
Improved libido, energy and body composition (men with low testosterone)
Steadier mood and clearer thinking as symptoms settle

Good News: The FDA Has Updated Its Hormone Therapy Labeling

For more than twenty years, menopausal hormone therapy carried the FDA’s most prominent form of warning label. That language dated to 2003 and rested on a single large study of women who were, on average, 63 years old and using a hormone formulation that is rarely prescribed today. Clinicians argued for years that it did not reflect the experience of the women who actually take hormone therapy now — typically women in their late forties and fifties, using different formulations, starting near the onset of menopause.

The FDA agreed. After a comprehensive review of the evidence, the agency announced in November 2025 that it was initiating removal of the broad warning, and on February 12, 2026 it approved the first updated labels — six products spanning all four categories of menopausal hormone therapy, with submissions from 29 manufacturers still moving through review. The agency also noted something patients rarely heard during those two decades: randomized data show lower all-cause mortality and fewer fractures among women who begin systemic hormone therapy within ten years of the onset of menopause, which for most women means before age 60.

For anyone who has been putting off a conversation about hormone therapy because of what they had read, this is the substance of what changed: the regulator that wrote the warning reviewed the evidence and concluded the warning overstated the risk. The labels now say what the data actually support.

Is Bioidentical Better Than Synthetic?

Not as a blanket rule — but two specific comparisons are well established in the evidence, and both favor the bioidentical option:

Comparison	What the Evidence Shows
Micronized progesterone vs. synthetic progestins	These are not interchangeable. Micronized progesterone is bioidentical, FDA-approved, and generally the preferred choice.
Patch or gel estradiol vs. oral estrogen	Transdermal estradiol is absorbed through the skin and skips first-pass liver metabolism, which is associated with a lower clotting risk. Often the better choice.

These are the kinds of decisions a physician makes deliberately, patient by patient. Two people with the same symptoms can end up on different formulations for good reasons, and that flexibility is one of the practical advantages of working with bioidentical hormones.

FDA-Approved and Compounded Options: How They Work Together

An FDA-approved product is manufactured to a fixed specification and reviewed for safety and consistency — and, following the 2025–2026 labeling changes, now carries language that better reflects its real safety profile for most women. These products are an excellent starting point, and they cover most patients well.

A compounded preparation, such as a hormone pellet, works differently by design: it is prepared for one patient at a particular dose rather than mass-produced at a standard one. That is what allows a dose to be tailored to your labs instead of rounded to the nearest available strength, and it is why Dr. Temkin pairs compounded therapy with close lab monitoring — a baseline hormone panel before starting, a recheck partway through the cycle, and levels reviewed before every pellet insertion. The 2020 NASEM review of compounded hormone therapy found that the evidence gap was a shortage of large, high-quality studies, not evidence of harm. Physician-directed lab monitoring is exactly how that gap is closed in practice.

Which Option Is Right for You?

That depends on your symptoms, your health history and what your lab work shows. FDA-approved patches, gels and capsules work well for most people and are a natural place to start. For many patients, pellets turn out to be the better long-term fit: steady hormone levels, no daily routine to keep up with, and three or four visits a year instead of a daily task. It is the delivery method Dr. Temkin uses most often in this practice. Either way, your dose is set from your own numbers and rechecked on a schedule — the formulation changes, the monitoring does not.

About Dr. Michael Temkin, DO

Dr. Michael Temkin, DO is an internal medicine physician who has been in private practice in San Ramon for 25 years, and he is a Certified BioTE Provider. He prescribes across the full range of bioidentical options — FDA-approved patches, gels, sprays, rings and micronized progesterone, as well as compounded preparations including pellets — and chooses among them based on your symptoms, your health history and your lab work rather than a single default protocol.

Hormone therapy at Temkin Health is handled the way the rest of his internal medicine practice is handled: by him, in his own office. He orders and interprets the labs, performs pellet insertions himself, reviews follow-up levels and adjusts each dose personally. Because Temkin Health is a concierge practice, appointments are unhurried and patients can reach him directly with questions between visits. Hormone therapy also sits alongside the practice’s concierge primary care, the LeanMD medical weight loss program and its longevity medicine services, so hormone optimization is managed in the context of your overall metabolic health rather than in isolation.

Frequently Asked Questions

What is bioidentical hormone replacement therapy (BHRT)?

BHRT uses hormones that are chemically identical to the ones your body produces on its own — mainly estradiol, progesterone and testosterone. Because the molecules match, they bind to your body’s own hormone receptors in the same way. BHRT is available as FDA-approved patches, gels, sprays, rings and micronized progesterone capsules, and as compounded preparations such as hormone pellets.

What are the benefits of BHRT?

For women: relief from hot flashes, night sweats and disrupted sleep, relief from vaginal dryness and urinary symptoms, and support for bone density. For men with low testosterone: improved energy, libido, muscle mass and body composition. Many patients also report steadier mood and clearer thinking as their symptoms settle.

Is BHRT safe?

For most patients, yes — and the official picture has improved. In November 2025 the FDA asked manufacturers to remove the long-standing boxed warning from menopausal hormone therapy after reviewing the evidence, and in February 2026 it approved the first batch of updated labels. The agency also highlighted randomized data showing lower all-cause mortality and fewer fractures among women who start systemic hormone therapy within ten years of menopause. Specific choices still matter — a patch rather than a pill, for instance — and that is what your physician selects for you at the consultation.

Are bioidentical hormones FDA-approved?

Many are: estradiol patches, gels, sprays and rings, and micronized progesterone capsules are all FDA-approved bioidentical products. Compounded preparations such as pellets are made for the individual patient rather than mass-produced, which is what allows the dose to be matched to your lab work — and why Dr. Temkin verifies hormone levels before every insertion and again partway through the cycle.

What is the difference between bioidentical and synthetic hormones?

Bioidentical hormones have the same molecular structure as the hormones your body makes. Synthetic analogues, such as progestins, are structurally different molecules designed to produce a similar effect. Two comparisons have solid evidence behind them: micronized progesterone is generally preferred over synthetic progestins, and transdermal estradiol carries a lower clotting risk than oral estrogen because it bypasses the liver.

Talk to Dr. Temkin About Bioidentical Hormone Therapy

If you are trying to work out which formulation is right for you, that decision should follow from your symptoms, your risk factors and your lab work. Call Temkin Health at (925) 866-3900 or request a consultation online.

About Temkin Health

Temkin Health is a concierge internal medicine practice at 1081 Market Place, Suite 300, San Ramon, CA 94583, led by Dr. Michael Temkin, DO, who has been in private practice in San Ramon for 25 years. The practice offers concierge primary care, the LeanMD medical weight loss program, bioidentical hormone replacement therapy for men and women, and longevity medicine. Dr. Temkin is a Certified BioTE Provider. Phone: (925) 866-3900.

Sources

US Food and Drug Administration / HHS. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. November 10, 2025. https://www.fda.gov/news-events/press-announcements/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy
US Food and Drug Administration. FDA Approves Labeling Changes to Menopausal Hormone Therapy Products. February 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
Makary MA, Nguyen CP, Høeg TB, Tidmarsh GF. Updated Labeling for Menopausal Hormone Therapy. JAMA, 2025. https://jamanetwork.com/journals/jama/fullarticle/2841321
National Academies of Sciences, Engineering, and Medicine. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. 2020. https://www.nationalacademies.org/read/25791/chapter/1
The 2022 hormone therapy position statement of The North American Menopause Society. Menopause, 2022. https://journals.lww.com/menopausejournal/fulltext/2022/07000/the_2022_hormone_therapy_position_statement_of_the.4.aspx
Pinkerton JV, Santoro N. Compounded bioidentical hormone therapy: new recommendations from the 2020 National Academies of Sciences, Engineering, and Medicine. Menopause, 2021. https://pubmed.ncbi.nlm.nih.gov/33739316/

Disclaimer

This article provides general health information and is not medical advice for any specific situation. Reading it does not create a doctor-patient relationship. Hormone therapy is a prescription treatment with risks as well as benefits, and suitability is determined at a medical consultation with a licensed clinician. Results vary between individuals; every figure cited describes findings in studied populations rather than a predicted individual outcome. Compounded preparations, including compounded pellets, are not FDA-approved, which means the FDA does not evaluate them for safety, effectiveness or quality. Consult a licensed healthcare provider to discuss all treatment options, including potential risks and benefits.

Last updated September 2026.