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. This article explains what happens during the 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 periods have stopped permanently, confirmed after 12 consecutive months without one. The average age in the United States is 52. The years leading up to it are called perimenopause, and most women enter this transition between ages 45 and 55.
During perimenopause, the ovaries produce estrogen and progesterone less predictably, then progressively less. Symptoms can include hot flashes, night sweats, sleep disturbance, joint discomfort, vaginal dryness and pain with sex, mood changes and difficulty concentrating. Symptoms typically last between two and eight years but vary widely.
Two clusters matter most for treatment decisions. Vasomotor symptoms (hot flashes and night sweats) are driven by the brain's response to falling estrogen. Genitourinary symptoms (vaginal dryness, discomfort with sex, urinary urgency and recurrent infections) 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 such as progesterone is added to protect the uterine lining, because estrogen alone increases the risk of endometrial cancer.
FDA-approved products come in several forms: estradiol tablets, patches and gels for systemic symptoms; oral micronized progesterone; combined products; and low-dose vaginal estrogen that acts locally with minimal absorption. The 2022 position statement of The North American 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 statement says risk differs by type, dose, duration, route, timing of initiation and whether a progestogen is used. For women under 60 or within 10 years of menopause onset without contraindications, it concludes the benefit-risk balance is favorable for bothersome hot flashes and preventing bone loss. Transdermal estrogen (patches and gels) appears to carry a lower risk of blood clots than oral estrogen.
Contraindications to systemic therapy generally include a history of breast cancer or other estrogen-sensitive cancers, unexplained vaginal bleeding, active liver disease, and a history of blood clots or stroke.
In November 2025, the FDA requested that manufacturers revise the labeling of menopausal hormone therapies, including removing language about cardiovascular disease, breast cancer and probable dementia from the boxed warning, 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 retained for estrogen-alone products, and information about other risks remains elsewhere in the labeling. The takeaway is not that hormone therapy is risk-free; it is that for the right woman at the right time, the decision should be individualized.
Compounded preparations such as Biest (a combination of estriol and estradiol) are often marketed as "bioidentical." That term simply means the molecule matches what the body makes, and several FDA-approved products already meet that definition. Compounded hormone preparations are not FDA-approved. A 2020 National Academies report found insufficient evidence to support their overall clinical utility and recommended limiting their use to patients with a documented need an approved product cannot meet.
Biest cream offered through Oh My Body Studio is a compounded medication and is not FDA-approved. Your licensed provider should explain why a compounded product is being considered instead of an approved one.
The 2023 nonhormone therapy position statement lists options with good evidence for hot flashes, including cognitive behavioral therapy, certain antidepressants, gabapentin, and fezolinetant, an FDA-approved non-hormonal prescription medication. For genitourinary symptoms, over-the-counter moisturizers and lubricants are the first step.
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. This article is educational and does not determine eligibility for any treatment.
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.
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