Balancing Your Hormones With Hormone Replacement Therapy

Hormone replacement therapy (HRT) is the use of prescription hormones, usually estrogen, progesterone, testosterone or thyroid hormone, to replace what the body has stopped producing in the same amounts. It is most often prescribed around menopause or andropause, and it comes as patches, tablets, capsules, creams, gels, troches and vaginal preparations. Some of those are FDA-approved products and some are prepared by a compounding pharmacy to an individual prescription, which is not the same thing.

What is hormone replacement therapy?

Ovarian production of estradiol and progesterone falls during the menopause transition, and testosterone production in men declines gradually with age. Hormone therapy supplies one or more of those hormones from outside the body. The reasons a clinician raises it are usually vasomotor symptoms (hot flashes and night sweats), sleep disruption, genitourinary symptoms such as vaginal dryness and painful intercourse, and bone loss.

Whether hormone therapy is appropriate for you, which hormone, at what dose, and in what form are all decisions for your prescriber, made against your history and your reason for asking. Bayview Pharmacy does not diagnose, recommend a dose, or decide who should be on therapy. Our part begins when a prescription arrives, and our hormone replacement therapy service page describes how we work with prescribers.

What are bioidentical hormones, and how is compounded different from FDA-approved?

"Bioidentical" describes a hormone whose molecular structure matches the one the human body makes: estradiol, estriol, progesterone, testosterone. It is a statement about chemistry, not about where the product came from and not about how well it works.

This is the point most articles on the subject get wrong. Bioidentical does not mean compounded. FDA-approved products containing bioidentical estradiol and bioidentical micronized progesterone have been on the market for years, in patches, gels, vaginal preparations and oral capsules. If you want a bioidentical hormone, an approved product may already exist in the form you need, and that is worth asking your prescriber before anything else.

Compounded bioidentical hormone therapy (cBHT) is different. A pharmacy prepares it from bulk drug substance to a specific prescription. It is not an FDA-approved drug product, it does not go through premarket review for safety or efficacy, and it does not carry the standardized labeling and boxed warnings that accompany approved hormone products. In 2020 the National Academies of Sciences, Engineering, and Medicine published a report on the clinical utility of compounded bioidentical hormone therapy and concluded that the available evidence did not support broad clinical use, recommending that cBHT be restricted to patients who cannot use an approved product, for example because of a documented allergy to an ingredient or a need for a dose or dose form that is not commercially made. Compounded Bi-Est and the other preparations described below sit in that second category.

Nobody at this pharmacy will tell you a compounded preparation is gentler, more natural or better tailored than an approved product. Those claims are not supported, and the NASEM report singled them out as a marketing problem rather than a clinical finding.

What forms does hormone therapy come in?

Route matters, because it changes how a hormone reaches the bloodstream and what it does on the way. The table below sorts the common forms by what is available as an approved product and what a pharmacy prepares.

Two practical differences sit behind that table. Oral estrogen passes through the liver before it reaches the rest of the body, which is why the venous clot risk described in the trial literature is not identical across routes, and why some prescribers choose a skin route such as an estradiol topical cream instead. Vaginal preparations are dosed low and act mainly on local tissue, which is why they are handled separately from systemic therapy in most guidelines.

Estriol is the exception worth naming. There is no FDA-approved estriol product in the United States, so any prescription for it is filled as a compounded preparation, and the published evidence for it is thinner than the evidence for estradiol. Bayview prepares vaginal estriol on a prescriber's order, in the strength and form the prescription specifies.

Why is progesterone prescribed alongside estrogen?

In a woman who still has a uterus, estrogen given on its own stimulates the endometrium, and long-term unopposed estrogen is associated in the literature with endometrial hyperplasia and endometrial cancer. A progestogen is added to oppose that effect. This is standard practice with approved and compounded therapy alike, and it is one of the specific risks the NASEM report raised about compounded regimens, where the progesterone component and its absorption are less predictable than in an approved product.

That opposition is why compounded micronized progesterone is so often prescribed next to an estrogen preparation rather than by itself.

Some prescriptions combine the two into a single preparation, and Bayview prepares Bi-Est with progesterone when a prescriber orders it that way. Whether the combination or two separate items suits a given patient is a clinical decision, not a pharmacy one.

Should hormone levels be tested to set a dose?

Salivary hormone testing is the claim to be most careful about. Saliva levels fluctuate widely across a single day, results vary between laboratories, and they correlate poorly with serum levels and with symptoms. Professional bodies including the Endocrine Society and ACOG have advised against using salivary hormone testing to guide hormone therapy dosing, and the NASEM report reached the same conclusion. A pharmacy that offers to set your dose from a saliva panel is not following that guidance.

In routine menopausal hormone therapy, prescribers generally titrate against symptoms and tolerability rather than chasing a target number. Blood testing has a defined place in specific situations, such as monitoring during testosterone therapy or investigating an unexpected response, and our post on testosterone therapy for women covers how that monitoring is usually handled.

What are the risks of hormone replacement therapy?

Hormone therapy carries real risks and they belong in the conversation before the first prescription. The Women's Health Initiative trials, published from 2002 onward, reported increased rates of stroke and venous thromboembolism with combined oral estrogen plus progestin, and an increased rate of breast cancer in the combined-therapy arm. Later analyses have emphasized that age at initiation and years since menopause change the balance considerably, which is why the same therapy is assessed differently at 51 than at 68.

Hormone therapy is generally not prescribed to people with a history of breast cancer or another estrogen-dependent cancer, unexplained vaginal bleeding, active liver disease, or a history of stroke or venous clots. A compounded preparation does not change any of that: it contains the same hormones, so it carries the same class risks, and it arrives without the standardized patient labeling that comes in an approved product's carton. Ask your prescriber to walk you through the warnings that would apply.

Where do testosterone and other hormones fit?

Hormone therapy is not only estrogen. Low-dose testosterone for women is prescribed off-label in the United States, since no testosterone product is FDA-approved for women here; a 2019 Global Consensus Position Statement supports its use for postmenopausal hypoactive sexual desire disorder and notes that the evidence for other indications is insufficient. DHEA is prescribed by some clinicians as an oral, topical or vaginal preparation, and thyroid hormone is a separate question handled with its own testing.

In men, declining testosterone is assessed with morning serum testing repeated on separate days rather than assumed from symptoms, and our overview of testosterone replacement therapy sets out how that workup usually runs. Testosterone is a Schedule III controlled substance, dispensed only on a prescription written for a named patient, and controlled substances are not shipped to New York addresses.

What does compounded hormone therapy cost?

Compounded Bi-Est starts at $125, and combined Bi-Est with progesterone starts at $70, with the final price set by the strength, ratio, dose form and quantity written on the prescription. Compounded preparations are not billed through insurance: each one is made to an individual prescription rather than carrying a national drug code, so they are paid for directly and we quote the price before anything is prepared. Questions about payment, refills and the states where Bayview is licensed to ship are answered on our frequently asked questions page.

What does Bayview compound for hormone therapy?

On a prescriber's order, Bayview Pharmacy prepares Bi-Est (estriol and estradiol) in topical and oral forms from $125, Bi-Est with progesterone from $70, micronized progesterone in topical and oral forms from $110, estradiol topical cream and vaginal estradiol, vaginal estriol from $70, DHEA for women as an oral, topical or vaginal preparation from $70, low-dose testosterone for women from $90, and compounded T3/T4 thyroid capsules from $130. These are non-sterile preparations made under USP 795 non-sterile compounding standards in our lab in Warwick, Rhode Island.

The strengths, ratios and dose forms come from the prescription, which is the practical reason a prescriber sends an order to a compounding pharmacy: a ratio or a concentration that is not commercially manufactured. The full hormone replacement therapy category lists what we prepare in this area.

Preparations outside hormone therapy, from dermatology to pain and veterinary compounding, are listed in the searchable catalog of everything Bayview compounds.

Talk to your prescriber

If you are weighing hormone therapy, the useful next conversation is with the clinician who knows your history. Bring your symptoms, your family history of breast cancer and clotting, and the question of whether an FDA-approved product would do the job before a compounded one is considered. If a compounded preparation is the right answer, your prescriber can send the order to us directly.

Patients looking for a pharmacy to fill a compounded hormone prescription can read how we take in a new prescription in our guide to finding a compounding pharmacy near you, or call the pharmacy in Warwick with the prescription in hand.