● TIER 1 — FDA-approved / recognizedGRADE AEstrogen / progesterone
Estradiol / Progesterone (menopause HRT)
Sex steroids. Research verification: Yes (TGA pending). 4 human study record(s) in the FitClinicMD studies database.
GOALS · Hormone optimization / menopause / low T
FDA status
Approved (many).
Compounding (503A/503B)
Approved; compounded bioidentical common (not FDA-approved).
DEA
Not controlled.
WADA (sport)
Not listed on 2026 Prohibited List (no matching section found)
Mechanism
ER/PR agonists.
Human evidence · 4
NAMS 2022 position statement. The 2022 hormone therapy position statement of The North American Menopause Society.
KEEPS summary. The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?
ELITE n=643: early estradiol slowed CIMT progression. Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol.
WHI E+P, n=16,608: increased CHD, stroke, breast cancer; fewer fractures. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial.
Reference only. This page summarizes publicly available regulatory and research information about Estradiol / Progesterone (menopause HRT). It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.