Bioidentical hormone replacement therapy (BHRT) uses hormones that are chemically identical to those produced by the human body. This guide explains how BHRT is used, the differences between FDA-approved and compounded products, potential benefits and risks, and what an individualized care plan and monitoring typically look like—so you can have an informed conversation with your clinician.
Key Takeaways
Bioidentical hormones (such as 17-β estradiol and micronized progesterone) are available in FDA-approved formulations. Compounded bioidentical hormones are not FDA-approved and have not been evaluated by the FDA for safety, effectiveness, or manufacturing quality.
Menopausal hormone therapy has FDA-approved indications (e.g., treating moderate–severe vasomotor symptoms and prevention of postmenopausal osteoporosis). Treatment choice, dose, and route should be individualized and periodically reassessed.
Testosterone products are FDA-approved for certain men with diagnosed hypogonadism. They are not approved to treat age-related low testosterone or for performance-related goals, and they are not approved for women in the U.S.
Because responses and risks vary, ongoing clinical evaluation and monitoring are essential for anyone on hormone therapy.
What Are “Bioidentical” Hormones?
“Bioidentical” refers to hormones with the same chemical structure as human hormones. Some bioidentical options are FDA-approved, commercially manufactured medicines (for example, estradiol patches/gels and micronized progesterone capsules). Others are custom-compounded preparations made for an individual patient. Compounded drugs can be appropriate in limited situations (e.g., an allergy to an ingredient in a commercial product), but they do not undergo FDA review for safety, effectiveness, or quality, and can vary in strength and purity. Talk with your clinician about whether an FDA-approved option can meet your needs before considering compounded products.
How BHRT Is Used (and When)
BHRT is typically discussed for symptoms related to menopause or other well-defined hormone deficiencies. For menopausal symptoms, FDA-approved hormone therapy may be considered for moderate to severe hot flashes/night sweats and, for appropriate candidates, prevention of postmenopausal osteoporosis. Therapy selection depends on symptoms, age, time since menopause, personal risk factors, route of administration, and patient preference.
Important for men: Prescription testosterone is approved only for men with clinically diagnosed hypogonadism due to specific medical causes confirmed by laboratory testing. It is not approved for treating age-related low testosterone, vitality, or performance goals. Decisions should be made with a qualified clinician after appropriate evaluation.
Potential Benefits (Carefully Qualified)
Some patients report improvement in menopausal vasomotor symptoms and related quality-of-life measures when treated with FDA-approved hormone therapy, as supported by professional guidelines. Benefits depend on the individual, the formulation, dose, treatment duration, and health history. Compounded bioidentical products lack robust, head-to-head evidence and standardized labeling, so their benefits and risks are less certain.
Risks, Safety, and Monitoring
Hormone therapy is not one-size-fits-all. Potential risks vary by patient and product (e.g., estrogen with or without progestogen, dose, route).
General considerations: possible effects on the breast and endometrium (with unopposed estrogen), cardiovascular and thromboembolic risks in some populations, and other formulation-specific effects.
Compounded preparations: variability in dosing and lack of FDA oversight can introduce quality and safety concerns.
Testosterone: for men with confirmed hypogonadism, product labeling includes safety information and monitoring recommendations. Labels retain a limitation of use for age-related low testosterone.
Monitoring: Expect periodic clinical follow-up to review symptoms, side effects, and—when indicated—lab tests and age-appropriate cancer screening.
Your clinician will weigh potential benefits and risks for your situation and discuss the lowest effective dose for the shortest appropriate duration consistent with your goals and guidelines.
Routes and Formulations
FDA-approved bioidentical options include several estradiol formulations (patches, gels, sprays, tablets, rings) and oral micronized progesterone.
Compounded forms (e.g., certain creams or pellets) may be offered in some settings but are not FDA-approved; quality and dosing can vary. If a compounded product is considered, clarify why an FDA-approved alternative isn’t suitable and how safety will be monitored.
Getting Started: What to Expect
Evaluation: Medical history, symptom assessment, and, when relevant, targeted labs.
Shared decision-making: Review indications, options (including nonhormonal), potential benefits/risks, and your preferences.
Personalized plan: Choice of FDA-approved formulation and route when possible; discussion of treatment goals.
Follow-up: Reassess benefits/risks, adjust dose or route if needed, and continue age-appropriate screenings.
Lifestyle Still Matters
Whether or not you use hormone therapy, bone-healthy nutrition, regular physical activity, sleep, stress management, tobacco avoidance, and moderation of alcohol support overall health. For hot flashes, some patients also explore evidence-based nonhormonal options discussed in professional guidelines.
Services at Body Balance Medical (Our Approach)
We emphasize individualized care. When appropriate, we prioritize FDA-approved options that align with current guidelines and your medical history. If a compounded product is considered necessary (e.g., a documented intolerance to an ingredient in an approved product), we’ll discuss why, how dosing will be determined, and what monitoring plan will be in place.
Schedule a hormone consultation today!
FAQs
Are bioidentical hormones “safer” than other hormones?
Not necessarily. Some bioidentical hormones are FDA-approved and have standardized labeling and safety data. Compounded bioidentical products are not FDA-approved; their safety and effectiveness have not been established by the FDA.
Can testosterone be used for age-related low energy or for women?
No. In the U.S., testosterone products are approved only for certain men with clinically diagnosed hypogonadism. They are not approved for age-related low testosterone or for women.
What about pellets?
Pellets are typically compounded and not FDA-approved. Discuss alternatives and monitoring if pellets are proposed.
How long should I stay on therapy?
Duration is individualized. Regular check-ins with your clinician help ensure that benefits continue to outweigh risks.
