Hormone therapy · FDA-approved bioidenticals

Hormone replacement therapy for women, evidence-based menopause care.

For women navigating perimenopause and menopause, hormone replacement therapy (HRT) is among the most evidence-backed interventions available. When initiated at the right time and in the right formulation, FDA-approved bioidentical HRT addresses hot flashes, sleep disruption, bone loss, and genitourinary changes, restoring quality of life that hormone decline often quietly erodes.

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What it is

Hormone replacement therapy (HRT) replaces the ovarian hormones, estrogen and progesterone, that decline during perimenopause and stop after menopause. Many women also benefit from low-dose testosterone as an adjunct for energy and sexual function, though this is off-label.

FDA-approved bioidentical products use estradiol (the same molecule your ovaries produce) and micronized progesterone (identical to endogenous progesterone). These are structurally the same as your natural hormones, but they have also been tested in large clinical trials, manufactured under FDA oversight, and labeled with clear dosing and risk information.

Compounded bioidentical hormones (cBHT) custom-mixed by 503A pharmacies may be appropriate for patients who need specific doses or routes not available commercially, but the 2020 National Academies (NASEM) report documented variable potency and quality across cBHT preparations. Genesis prefers FDA-approved formulations when clinically appropriate.

How it works

Estradiol binds estrogen receptors in the brain, bone, vagina, urinary tract, and cardiovascular system. It stabilizes vasomotor centers in the hypothalamus (reducing hot flashes and night sweats), restores vaginal and urinary mucosal integrity (addressing dryness, dyspareunia, and recurrent UTIs), and preserves bone mineral density.

Progesterone opposes estrogen's proliferative effect on the uterine lining. In women with an intact uterus, progesterone is required to prevent endometrial hyperplasia and cancer when systemic estrogen is used.

Transdermal vs oral routes. Transdermal estradiol (patches, gels) bypasses hepatic first-pass metabolism, which results in a lower risk of venous thromboembolism (VTE) compared with oral estradiol. For most patients, transdermal is the preferred route for cardiovascular safety.

Low-dose testosterone (off-label). Approximately 1/10 of the male dose, administered as a topical gel or compounded cream, addresses androgen deficiency contributing to hypoactive sexual desire disorder (HSDD) and fatigue. Provider monitoring keeps levels in the female physiologic range.

Conditions and use cases

What HRT addresses.

  • Vasomotor symptoms: hot flashes and night sweats (the primary indication).
  • Sleep disturbance, often driven by vasomotor events or hormonal disruption of sleep architecture.
  • Mood symptoms: irritability, low mood, anxiety attributable to hormonal transition.
  • Genitourinary syndrome of menopause (GSM): vaginal dryness, dyspareunia, recurrent urinary tract infections.
  • Osteoporosis prevention in appropriate candidates, particularly those at elevated fracture risk.
  • Off-label: hypoactive sexual desire disorder (HSDD), low-dose testosterone for women with documented androgen insufficiency.

Expected timeline

What patients commonly observe.

  1. Week 0 to 2

    Vasomotor onset

    Vasomotor symptom relief begins. Fewer and less intense hot flashes.

  2. Week 2 to 4

    Sleep and mood

    Sleep and mood improvements emerge. Energy often improves.

  3. Month 1 to 3

    GSM resolution

    Genitourinary syndrome responds to vaginal estrogen. Full mucosal restoration may take 3+ months.

  4. Month 3 to 6

    Bone and reassessment

    Bone density gains begin to accrue with continued therapy per DEXA monitoring. Annual reassessment.

Stacks that include this therapy

HRT for women appears in this stack.

Investment and access

Care plans, not menus.

Genesis Longevity therapies are dispensed only after a complimentary consultation and Good Faith Exam. Schedule yours to receive a personalized plan tailored to your biology and goals.

Side effects

What patients commonly report.

Common during initiation. Breast tenderness and bloating. Irregular uterine bleeding (especially during perimenopausal cyclic therapy). Headache.

Route-specific. VTE risk is meaningfully higher with oral than with transdermal estradiol. Transdermal route is preferred for VTE-safety conscious prescribing.

Breast cancer risk (WHI re-analyses). Combined HRT (estrogen + progestogen) used for more than 5 years carries a small absolute increase in breast cancer risk, approximately 1 to 2 additional cases per 1,000 women per year. Estrogen-only therapy in women without a uterus shows neutral or modestly reduced risk in some analyses. Risk declines after discontinuation. Women with a personal history of breast cancer should not use systemic HRT.

Contraindications

Who should not use this therapy.

Show contraindications

Absolute. Personal history of breast cancer or estrogen receptor-positive cancer. Undiagnosed vaginal bleeding. Active venous thromboembolism, stroke, or recent myocardial infarction. Coronary heart disease without cardiology clearance. Severe liver disease. Pregnancy.

Use with individual risk-benefit discussion. Women with BRCA mutations, obesity, prior gallbladder disease, migraine with aura, or women outside the favorable timing window (more than 10 years since menopause or age over 60).

Pairs well with

Therapies that complement this protocol.

Frequently asked

Frequently asked questions about HRT for women.

Sources

Citations & references

  1. [1]NCBI StatPearls, Hormone Replacement Therapy. NBK493191. Source
  2. [2]Columbia OB/GYN, Menopause hormone therapy clinical review. Source
  3. [3]Bioidentical hormone therapy comparative review. PMC7716720.
  4. [4]Timing hypothesis meta-analysis. PubMed 30484736.
  5. [5]Breastcancer.org, HRT and breast cancer risk. Source
  6. [6]Wikipedia, Timing Hypothesis (menopausal hormone therapy). Source
  7. [7]NAMS, When women initiate estrogen therapy matters. Source
  8. [8]NASEM 2020 cBHT Consensus Report, National Academies of Sciences, Engineering, and Medicine.

Status & disclosures

FDA-approved bioidenticals available
Multiple FDA-approved bioidentical estradiol products (transdermal patches Climara and Vivelle-Dot; gels Divigel and EstroGel; oral Estrace) and oral micronized progesterone (Prometrium) are first-line at Genesis. Compounded bioidenticals are 503A and not FDA-approved.
Low-dose testosterone is off-label for women
Low-dose testosterone for HSDD or fatigue in women is off-label. Provider monitoring keeps levels within female physiologic range.
Provider supervision required
HRT requires a Good Faith Exam and provider consultation prior to initiation. Annual reassessment is standard.

Next step

Talk to a Genesis provider about HRT for women.

Schedule a consultation. Physician-led, evidence-graded.

Or keep reading: See the She Thrives stack