What changes during the menopausal transition, which symptoms hormone therapy treats, how FDA-approved products differ from compounded ones, and what the 2025 label changes mean.
Menopause is a normal stage of life, not a disease, but the years around it can bring symptoms that disrupt sleep, work, relationships and wellbeing. Hormone therapy is the most studied treatment for those symptoms, and it has also been the subject of two decades of confusion, much of it traceable to a single large study and the way its results were communicated. This article explains what happens during the menopausal transition, what hormone therapy does and does not treat, how FDA-approved products differ from compounded ones, and what changed in the FDA's labeling in late 2025. It is educational and not a substitute for an individual assessment by a licensed provider.
The National Institute on Aging describes menopause as the point when menstrual periods have stopped permanently, confirmed after 12 consecutive months without a period. The average age in the United States is 52. The years leading up to it are called perimenopause or the menopausal transition. Most women enter this transition between ages 45 and 55, and it can last several years.
During perimenopause, the ovaries produce estrogen and progesterone less predictably, then progressively less. Periods become irregular before stopping. Symptoms, when they occur, can include hot flashes, night sweats, sleep disturbance, joint and muscle discomfort, vaginal dryness and pain with sex, mood changes and irritability, and difficulty concentrating. The NIA notes that symptoms typically last between two and eight years but vary widely, and some women have few or none.
Two clusters matter most for treatment decisions. Vasomotor symptoms (hot flashes and night sweats) are driven by the brain's response to fluctuating and falling estrogen. Genitourinary symptoms (vaginal dryness, irritation, discomfort with sex, urinary urgency and recurrent urinary infections) result from thinning of estrogen-dependent tissue and, unlike hot flashes, tend to persist or worsen without treatment.
Menopausal hormone therapy replaces some of the estrogen the ovaries no longer produce. For women who still have a uterus, a progestogen (progesterone or a synthetic progestin) is added to protect the uterine lining, because estrogen alone increases the risk of endometrial cancer. Women who have had a hysterectomy typically use estrogen alone.
FDA-approved products come in several forms:
The 2022 position statement of The North American Menopause Society (now The Menopause Society) states that hormone therapy "remains the most effective treatment for vasomotor symptoms and the genitourinary syndrome of menopause and has been shown to prevent bone loss and fracture."
The same position statement makes the central point that risk "differs depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen is used." The most important variable is timing. For women under 60 or within 10 years of menopause onset who have no contraindications, the statement concludes that the benefit-risk balance is favorable for treating bothersome hot flashes and preventing bone loss. For women who start more than 10 years after menopause or after age 60, the balance appears less favorable because absolute risks of coronary heart disease, stroke, blood clots and dementia are higher at older ages.
Transdermal estrogen (patches and gels) appears to carry a lower risk of blood clots than oral estrogen, which is one reason route matters. Low-dose vaginal estrogen for genitourinary symptoms alone has a different and much smaller risk profile, and the position statement recommends it for women whose symptoms are not relieved by over-the-counter moisturizers and lubricants and who do not need systemic therapy.
Contraindications to systemic hormone therapy generally include a history of breast cancer, estrogen-sensitive cancers, unexplained vaginal bleeding, active liver disease, a history of blood clots or stroke, and known clotting disorders. A full history is part of any responsible prescribing decision.
For more than 20 years, FDA-approved menopausal hormone products carried a boxed warning referencing cardiovascular disease, breast cancer and probable dementia, based largely on the Women's Health Initiative trials of the early 2000s. Those trials enrolled women with an average age in the 60s, more than a decade past typical menopause onset, and used specific formulations that are less commonly prescribed now.
In November 2025, after a review of the literature, an expert panel and a public comment period, the FDA requested that manufacturers revise the labeling of menopausal hormone therapies. According to the FDA's statement, the requested changes include removing language about cardiovascular disease, breast cancer and probable dementia from the boxed warning; removing the recommendation to use the lowest dose for the shortest time; adding data from the Women's Health Initiative participants aged 50 to 59; and adding language supporting consideration of therapy for moderate to severe hot flashes in women under 60 or within 10 years of menopause. The boxed warning about endometrial cancer is being retained for systemic estrogen-alone products, and information about cardiovascular and breast cancer risks remains elsewhere in the labeling.
The practical takeaway is not that hormone therapy is risk-free. It is that the regulatory label now more closely reflects what the professional societies had already concluded: for the right woman at the right time, the benefits are substantial and the risks are modest and manageable, and the decision should be individualized.
Many clinics and pharmacies offer compounded hormone preparations marketed as "bioidentical," including custom creams such as Biest (a combination of estriol and estradiol), compounded progesterone and compounded testosterone. These products deserve a clear explanation.
The term "bioidentical" simply means the hormone molecule is structurally identical to the one the body makes. Several FDA-approved products already meet that definition, including estradiol patches, gels and tablets, and oral micronized progesterone. "Bioidentical" does not mean compounded, and it does not mean safer.
Compounded hormone preparations are not FDA-approved. The FDA does not review them for safety, effectiveness or quality before they are sold. In 2020, at the FDA's request, the National Academies of Sciences, Engineering, and Medicine published a consensus report on compounded bioidentical hormone therapy. The committee found insufficient evidence to support the overall clinical utility of these products, noted that they are frequently marketed as safer alternatives to approved products without evidence for that claim, and recommended that their use be limited to patients with a documented need that an approved product cannot meet, such as an allergy to an inactive ingredient or an unavailable dose form.
Any compounded hormone product available through NewDay Wellness, including Biest cream, is a compounded medication and is not FDA-approved. We state that on the product page, and a licensed provider should explain why a compounded product is being considered instead of an approved one.
Hormone therapy is not the only approach. The 2023 nonhormone therapy position statement of The North American Menopause Society lists several options with good-quality evidence for vasomotor symptoms: cognitive behavioral therapy, clinical hypnosis, certain antidepressants (SSRIs and SNRIs), gabapentin, and fezolinetant, an FDA-approved non-hormonal prescription medication that acts on the brain's temperature regulation pathway. Lifestyle measures such as managing weight, limiting alcohol, keeping the bedroom cool and layering clothing help some women. For genitourinary symptoms, over-the-counter moisturizers and lubricants are the first step.
Menopause is the point when periods have stopped permanently, confirmed after 12 consecutive months without one. Perimenopause is the transition before it, when hormone production becomes irregular and symptoms often begin.
It is not risk-free, but for women under 60 or within 10 years of menopause onset without contraindications, The Menopause Society concludes the benefit-risk balance is favorable for bothersome hot flashes and preventing bone loss. Risk depends on type, dose, route, timing and whether a progestogen is used.
No evidence shows that. Bioidentical only means the molecule matches the body's own, and several FDA-approved products already meet that definition. Compounded bioidentical preparations are not FDA-approved or reviewed for safety, effectiveness or quality.
Yes. Options with good evidence include cognitive behavioral therapy, clinical hypnosis, certain SSRIs and SNRIs, gabapentin and fezolinetant, an FDA-approved non-hormonal prescription medication.
The menopausal transition is individual, and so is the decision about treatment. A licensed provider can take a full history, discuss approved and compounded options honestly, and help you weigh benefits and risks for your situation. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
Estradiol and progesterone are available as FDA-approved products that are chemically identical to the body's hormones. Biest is a compounded cream that mixes estriol with estradiol; it is not FDA-approved, and expert bodies advise using it only when an approved product will not work.
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