What Does "Bioidentical" Actually Mean?
A bioidentical hormone has the same molecular structure as a hormone the human body produces naturally. The term describes the hormone molecule itself. It does not mean the medication must be compounded, and it does not, on its own, mean a treatment is safer.
Bioidentical hormone therapy uses hormones with a chemical structure identical to hormones produced naturally by the human body. Examples include 17β-estradiol and micronized progesterone. Women and men also produce testosterone naturally, and it may be used for specific clinical indications.
At ReNew Me Medical Group, hormone therapy is individualized according to symptoms, menopausal stage, medical history, risk factors, uterine status, treatment goals and clinical response.
FDA-Approved vs. Compounded Bioidentical Hormones
Patients often hear "bioidentical hormone therapy" and assume it refers only to customized medications from a compounding pharmacy. It does not. There are two broad categories.
FDA-Approved Bioidentical Hormones
These are commercially manufactured products containing hormones such as estradiol and micronized progesterone. FDA-approved medications are evaluated for safety, effectiveness, manufacturing consistency, potency, quality and labeling.
Compounded Bioidentical Hormones
These are customized preparations made by a compounding pharmacy according to a clinician's prescription. Compounding can be useful when a patient needs a dose, formulation or ingredient combination that is not commercially available, or cannot tolerate an ingredient in an approved product.
Compounded hormone products do not undergo FDA premarket approval for safety, effectiveness or manufacturing consistency. ACOG recommends FDA-approved menopausal hormone therapies over compounded preparations when suitable approved products exist.
Hormones Used in Bioidentical Hormone Therapy
Estradiol
Estradiol is the principal estrogen produced by the ovaries during the reproductive years. FDA-approved estradiol is available as transdermal patches, gels, sprays, oral tablets or capsules, and vaginal preparations.
The route matters. Oral estradiol passes through the liver first, which affects clotting proteins, triglycerides, SHBG, LDL cholesterol and Apo B. Estradiol delivered by patch, gel or spray is absorbed through the skin and largely avoids that first pass. The Menopause Society notes that transdermal routes and lower doses may decrease the risk of blood clots and stroke compared with some oral regimens. Route is one of the variables your provider weighs, not a guarantee of safety.
Progesterone
The body produces progesterone naturally after ovulation. FDA-approved oral micronized progesterone is chemically identical to the progesterone your body makes.
Women who have a uterus and use systemic estrogen generally need adequate progestogen protection, because estrogen stimulates the uterine lining and can raise the risk of endometrial hyperplasia and endometrial cancer. Micronized progesterone is one option. Synthetic progestins are another, and they have different tolerability and pharmacologic profiles. Compounded progesterone cream should not be assumed to protect the uterus just because progesterone is on the label. Dose, route and absorption matter
Testosterone
Testosterone is a naturally occurring hormone in both women and men. In postmenopausal women, its best-supported use is treatment of hypoactive sexual desire disorder (HSDD) after appropriate clinical evaluation. It is not routinely indicated simply because a woman has entered menopause, and there is currently no FDA-approved testosterone product specifically for women in the United States, so treatment requires careful counseling and monitoring. For men, testosterone is used when lab results and symptoms together confirm low testosterone.
DHEA
DHEA is a hormone made mainly by the adrenal glands, which the body can convert into estrogen and testosterone. A vaginal DHEA product is FDA-approved for painful intercourse caused by menopause. Oral DHEA is sold as a dietary supplement, so your provider discusses whether it fits your situation.
Thyroid Hormones
FDA-approved levothyroxine (T4) and liothyronine (T3) are chemically identical to the thyroid hormones your body makes and are used to treat diagnosed hypothyroidism. Thyroid symptoms such as fatigue, weight change and low mood overlap with menopause and low testosterone, so thyroid testing is often part of a full hormone evaluation. Learn more about thyroid treatment.
How Does BHRT Work?
At ReNew Me Medical Group, we test hormone levels after starting BHRT and adjust based on a combination of blood levels and symptoms. Follow-up looks at:
- Symptom response: Are hot flashes, night sweats, sleep, vaginal symptoms or sexual-health concerns improving?
- Side effects: Breast tenderness, bleeding or spotting, headaches, bloating, mood changes, and androgenic symptoms when testosterone is used.
- Cardiometabolic health: Blood pressure, lipids, glucose or A1c, weight and body composition, as appropriate.
- Unexpected bleeding: Persistent or unexpected bleeding may need further evaluation and should not be written off as "hormone adjustment."
- Testosterone levels in women: Serum testosterone helps keep exposure within the normal female range.
- Periodic risk-benefit review: Dose, route, regimen and duration are reassessed as symptoms, health and risk factors change.
Who Needs Additional Evaluation Before Starting Hormone Therapy?
Some patients need a more detailed assessment before systemic hormone therapy is considered, including those with a personal history of:
- Breast cancer or another hormone-sensitive cancer
- Endometrial cancer
- Unexplained vaginal bleeding
- Deep-vein thrombosis, pulmonary embolism or a clotting disorder
- Stroke, heart attack or known cardiovascular disease
- Significant liver disease
Additional evaluation may also be appropriate with a strong family history of hormone-sensitive cancer, migraines, high triglycerides, gallbladder disease, major cardiovascular risk factors or abnormal uterine bleeding. These conditions do not always rule out hormone therapy. They mean the decision to treat, and the formulation, dose and route, need more individualization.
FAQs About BHRT
What does BHRT stand for?
BHRT stands for bioidentical hormone replacement therapy. The term usually refers to treatment with hormones chemically identical to hormones naturally produced by the body.
Are bioidentical hormones FDA-approved?
Some FDA-approved hormone medications contain hormones that are chemically identical to hormones produced by the human body, including certain estradiol and micronized progesterone products. Customized compounded hormone preparations are not FDA-approved. Whether an FDA-approved or compounded preparation is appropriate depends on the patient's clinical circumstances and should be discussed with the treating provider.
Is compounded BHRT safer than FDA-approved hormone therapy?
There is no good evidence that compounded bioidentical hormone therapy is safer or more effective than FDA-approved menopausal hormone therapy.
Does BHRT help women lose weight?
Hormone therapy is not a weight-loss treatment. Menopause influences fat distribution and body composition, but nutrition, muscle mass, physical activity, sleep and metabolic health remain important.
Do hormone levels need to be "optimized"?
No universal laboratory target defines optimal menopausal health. Treatment focuses on a recognized indication, symptom response, safety and individualized clinical goals rather than recreating hormone levels from young adulthood.
How long will I need hormone therapy?
No universal duration applies to every patient. Some women use hormone therapy for several years while symptoms are most bothersome, and others continue longer because symptoms persist or another indication remains. The Menopause Society states there is no universal age at which hormone therapy must stop, and continuing beyond 65 can be reasonable for selected women after an individualized risk-benefit review.