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Anastrozole Reference

Educational, not medical advice reference for Anastrozole: Hormonal; regulatory status, evidence posture, source review, and schedule notes. Also known as Ar…

Reference summary

On-label breast-cancer evidence is mature and supported by large randomized trials. The off-label male-TRT use case rests on smaller studies. Burnett-Bowie 2009 JCEM (n=69 older men with low testosterone) reported that anastrozole 1 mg daily for 12 months raised testosterone and lowered estradiol but also produced an unfavorable bone-mineral-density signal (a reduction in lumbar spine BMD), which is the principal reason aromatase inhibition is not first-line in male hypogonadism management.

Regulatory and posture

Categories
Hormonal
Aliases
Arimidex, Non-steroidal aromatase inhibitor (small molecule, not a peptide)
Evidence posture
human - Off-label male use is investigational. Bone-mineral-density signal in the Burnett-Bowie trial is the historical concern.
Regulatory status
FDA-approved as Arimidex (1995) for adjuvant treatment of hormone-receptor-positive early breast cancer in postmenopausal women, first-line treatment of locally advanced or metastatic breast cancer in postmenopausal women, and treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen. Off-label use in men on testosterone replacement therapy to control aromatization to estradiol is common clinical practice but is not an FDA-approved indication. WADA-prohibited at all times under S4 (aromatase inhibitors).
Content review status
label verified

Selected public sources