● TIER 1 — FDA-approved / recognizedGRADE AAndrogens / AAS
Testosterone (all esters, TRT)
Androgen. Research verification: Yes (TGA pending). 5 human study record(s) in the FitClinicMD studies database.
GOALS · Hormone optimization / menopause / low T · Muscle / body composition · Sexual function
FDA status
Approved for male hypogonadism (multiple products).
Compounding (503A/503B)
Approved; also compounded.
DEA
DEA Schedule III (anabolic steroid)
WADA (sport)
S1 Anabolic agents
Mechanism
AR agonist; esters (cypionate, enanthate, undecanoate), gels, pellets, oral TU.
Human evidence · 5
TRAVERSE fracture substudy: no fracture reduction (more fractures numerically). Testosterone Treatment and Fractures in Men with Hypogonadism.
TRAVERSE, n=5,246 men 45-80 y: noninferior MACE; more AF, AKI, PE. Cardiovascular Safety of Testosterone-Replacement Therapy.
Global consensus: HSDD in postmenopausal women only. Global Consensus Position Statement on the Use of Testosterone Therapy for Women.
TTrials, n=790 men ≥65: modest sexual function/mood benefits. Effects of Testosterone Treatment in Older Men.
Supraphysiologic 600 mg/wk enanthate, n=43: ↑muscle size/strength (bodybuilding-relevant). The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men.
Reference only. This page summarizes publicly available regulatory and research information about Testosterone (all esters, TRT). 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.
