Cleveland Clinic Menopause Center

Short answer Start by asking a clinician experienced in menopause care (OB/GYN, endocrinologist, or a North American Menopause Society–certified menopause practitioner) for an individualized plan. Favor FDA‑approved (traditional) HRT first because it has the best evidence on benefits, risks and consistent dosing. Consider compounded “bioidentical” HRT (BHRT) only if you have a clear, specific reason it’s needed and after discussing the trade‑offs. What “bioidentical” means — and why it’s confusing “Bioidentical” technically means the hormone molecule is chemically identical to human hormones (for example, micronized progesterone and estradiol are bioidentical). Several FDA‑approved products are bioidentical. BHRT in common use usually refers to compounded custom products (creams, troches, pellets) made by compounding pharmacies. Those are not FDA‑approved, don’t undergo the same large trials, and can vary in potency and purity. Evidence, safety and regulation — practical differences Traditional (FDA‑approved) HRT: products such as estradiol patches (Vivelle‑Dot, Climara), oral estradiol (Estrace), conjugated estrogens (Premarin), and micronized progesterone (Prometrium) have clinical trials, known dosing, standardized manufacturing, and clearer safety data. Insurance coverage is often available. Compounded BHRT: appeals for “custom doses” or nonstandard routes (creams, pellets), but lacks robust safety/efficacy studies. Labs used to guide dosing (like saliva tests) are unreliable. There is risk of inconsistent dosing, contamination, and higher out‑of‑pocket cost. Professional societies (NAMS, ACOG, Endocrine Society) advise caution about compounded BHRT. Common BHRT approaches to be cautious about Pellets (subcutaneous pellets, often marketed by networks such as BioTE): convenience, but limited high‑quality evidence, variable hormone release, and possible insertion complications. Custom creams or troches compounded based on saliva tests: not recommended because dosing and monitoring are unreliable. Which you should ask for (practical approach) Describe your symptoms, medical history, and priorities (symptom relief, bone protection, fear of risks such as breast cancer or blood clots). Ask for an evidence‑based discussion of options: FDA‑approved estrogen ± appropriate progestogen if you have a uterus, routes (patch, oral, gel), expected benefits and risks, and monitoring. Example FDA‑approved options to discuss: Estradiol patch: Vivelle‑Dot, Climara (stable blood levels; lower clot risk than some oral estrogens) Oral estradiol: Estrace Conjugated estrogens: Premarin (well‑studied historically) Progesterone: Prometrium (micronized progesterone, bioidentical form; differs from medroxyprogesterone/Provera) If you prefer “bioidentical” phrasing, ask whether the prescribed FDA‑approved hormones are bioidentical (many are). If standard therapy doesn’t work or causes side effects, or you have a specific rationale for compounded therapy, ask your clinician to explain the pros/cons and refer you to a reputable compounding pharmacy and skilled prescriber if proceeding. Where to go / whom to ask Primary options: your OB/GYN, a primary care physician experienced in menopause, or an endocrinologist. For complex questions or personalized plans, see a menopause specialist: look for a North American Menopause Society (NAMS) Certified Menopause Practitioner (NCMP) or a menopause clinic at an academic center (examples: Mayo Clinic Menopause Clinic, Cleveland Clinic Menopause Center). NAMS has a “find a practitioner” resource. If you’re considering compounded BHRT: only proceed with a clinician who understands the limitations and uses reputable compounding pharmacies that follow USP and state board standards. Ask the clinician which compounding pharmacy they use and whether it’s accredited (URAC/PCAB or equivalent). Monitoring and safety Before starting: review medical history (breast cancer, blood clots, liver disease, stroke), baseline mammogram as indicated, and discuss VTE/stroke risks. Follow‑up: assess symptom response and side effects at regular intervals; use the lowest effective dose for the shortest needed time for symptom control; bone density testing if bone protection is a goal. Avoid saliva testing for dose adjustment. Cost and coverage FDA‑approved HRT is more likely to be covered by insurance. Compounded BHRT is typically out‑of‑pocket and can cost more long‑term. Bottom line recommendation Ask a menopause‑experienced clinician for an individualized plan and start with an FDA‑approved HRT option that meets your goals and risk profile. Consider compounded BHRT only when a knowledgeable clinician explains why it’s necessary and you accept the uncertainties; if chosen, use an accredited compounding pharmacy and careful follow‑up. If you want, tell me: your age, symptoms, whether you have a uterus, and any medical history (blood clots, breast cancer, stroke, liver disease) and I’ll suggest what to ask a clinician and which specific HRT options to discuss.

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Short answer Ask for evidence-based hormone therapy under medical supervision — ideally FDA‑approved formulations of estradiol and, if you still have a uterus, micronized progesterone. That gives predictable dosing, known risks/benefits, and quality control. “Compounded BHRT” (custom-made hormones from compounding pharmacies) and hormone pellets are frequently promoted but have less oversight and weaker safety data. If you want a “bioidentical” product, choose FDA‑approved bioidentical estradiol and progesterone rather than compounded mixes. What those terms mean (brief) Traditional HRT: often refers to FDA‑approved estrogen and progestin products (examples: Premarin, Provera). Effective, well-studied. Bioidentical HRT (BHRT): means the hormone molecule matches human hormones (e.g., 17β‑estradiol, micronized progesterone). Some BHRT products are FDA‑approved (Estrace, Vivelle‑Dot, Climara, Prometrium). “Compounded BHRT” are custom mixtures made by compounding pharmacies — not FDA‑reviewed and variable quality. Which to ask for (practical recommendation) Start with FDA‑approved, evidence‑based therapy. Good, commonly used choices: Estradiol transdermal patch (Vivelle‑Dot, Climara, Alora) — transdermal route may have lower risk of venous thromboembolism than oral estrogen. Oral estradiol (Estrace) if oral route preferred. Micronized progesterone (Prometrium) if you have a uterus — protective for the endometrium and more “bioidentical” than synthetic progestins. For local vaginal symptoms, low‑dose vaginal estrogen (Vagifem, Estrace cream) is effective and low systemic exposure. If a clinician or you specifically want “bioidentical,” request FDA‑approved estradiol and micronized progesterone rather than compounded formulations. Avoid hormone pellets unless you’ve had a detailed discussion about risks/limited evidence and possible complications. Where to go / who to ask Primary options: Your primary care physician or your gynecologist — straightforward place to start. A menopause specialist or a dedicated menopause clinic for complex cases or if you want deeper consultation. Examples: Mayo Clinic Menopause Clinic, Cleveland Clinic Menopause Center, or academic medical centers in your region. Telehealth clinics specializing in menopause care can be convenient; examples include Plume (menopause-focused) and Tia (women’s health) — they provide clinician oversight and prescriptions. Verify they do appropriate screening and follow‑up. If a compounding pharmacy is needed (e.g., for a unique dose), use a PCAB‑accredited compounding pharmacy — search the PCAB directory. Examples of large compounding pharmacies that many clinicians use: Wedgewood Pharmacy, Fagron (but check local reputation and accreditation). What to discuss with the clinician Your symptoms, age, years since menopause, medical history (breast cancer, clotting, stroke, liver disease, cardiovascular disease), family history. Risks and benefits specific to your age/timing (starting HRT within ~10 years of menopause or under age 60 generally has a more favorable risk/benefit profile). Route: transdermal vs oral (transdermal often preferred if clot risk or high triglycerides). If you have a uterus, the need for progesterone to prevent endometrial cancer (Prometrium is a common bioidentical choice). Avoid saliva hormone testing for dosing — it’s unreliable. Baseline tests you’ll likely need: blood pressure, routine age-appropriate screening (mammogram as recommended), and follow-up plans. Suggested phrasing to bring to your appointment “I’m having [hot flashes/sleep problems/vaginal dryness]. I’d like to discuss hormone therapy. I’d prefer bioidentical estradiol and micronized progesterone (for example, transdermal estradiol patch and Prometrium) because I want an FDA‑approved, well‑studied option. Can we review my risks and the monitoring plan?” If considering compounded BHRT: “If you recommend compounded hormones, can you explain why an FDA‑approved option isn’t appropriate, and could we use a PCAB‑accredited pharmacy?” Safety notes HRT has benefits (relief of hot flashes, prevention of bone loss, improved quality of life) and risks (breast cancer, clotting, stroke — which vary by age, route, and type). Individualized assessment is essential. Compounded BHRT lacks the same regulatory oversight and consistent dosing; choose FDA‑approved products when possible. If you want, tell me: Your age, whether you still have a uterus, main symptoms, and any relevant medical history (clotting, breast cancer, heart disease). I can suggest a more tailored starting conversation and specific product choices.

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