No Testosterone Product Is FDA-Approved for Women

TODAY'S TOPIC

Testosterone and Women Over 40

Testosterone prescriptions for women have risen 146% since 2023, making it one of the fastest-growing prescriptions in menopause care. Much of that demand rests on assumptions that sound right but do not hold up.

CLAIM 01

Menopause causes a sharp drop in testosterone the way it does with estrogen.

VERDICT: MYTH

Estrogen falls off a cliff at menopause, so it feels logical that testosterone follows the same pattern. Social media widely promotes testosterone as essential menopause care for brain fog, fatigue, and low mood, reinforcing the parallel.

A 2025 study in eBioMedicine measured testosterone in 1,104 women aged 40 to 69 using LC-MS/MS assays, the most accurate method for measuring hormones in blood. No measurable differences appeared between premenopausal, perimenopausal, and postmenopausal women. Well-established research now shows testosterone declines about 50% from age 20 to 60, a gradual slope that begins in the twenties, has no relationship to when periods stop, and reflects the postmenopausal ovary still producing 40% to 50% of a woman's testosterone.

A woman at 50 should not assume menopause suddenly crashed her testosterone. The decline started decades earlier and is tied to age, not menopausal status. That distinction matters when deciding whether supplementation corrects a menopause-caused deficit or addresses something else entirely.

The ovaries do not retire from testosterone production when periods stop.

THE RESEARCH

Testosterone and pre-androgens by age and menopausal stage at midlife: findings from a cross-sectional study - eBioMedicine

Testosterone levels decline with age, not menopause, study finds

CLAIM 02

A blood test can tell you whether your testosterone is too low to explain your symptoms.

VERDICT: MYTH

It works that way for so many other hormones: thyroid levels diagnose thyroid disease, blood sugar levels diagnose diabetes. It seems natural that a testosterone number would tell you who needs treatment, especially when clinicians order it as part of a hormone panel and point to results as "low."

A 2019 global consensus position statement, endorsed by 11 international medical societies including the Endocrine Society, concluded that no blood testosterone level can distinguish women who have sexual dysfunction (persistent problems with desire, arousal, or satisfaction) from women who do not. A JAMA study of 1,021 women confirmed that no single androgen level predicted low sexual function. Women with identical testosterone concentrations can have completely different symptom profiles.

If a clinician points to a "low" testosterone number as the reason for fatigue or low desire, well-established evidence does not support using that number alone to make the call. A blood draw before starting treatment is useful to rule out already elevated levels. The diagnosis itself is clinical, based on symptoms and history, not a lab value.

Eleven medical societies agree: the number on the lab printout is not the answer.

THE RESEARCH

Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Climacteric, 2019)

Circulating Androgen Levels and Self-reported Sexual Function in Women (JAMA)

Testosterone Levels In Women (Mayo Clinic Press)

CLAIM 03

Testosterone therapy for women is FDA-approved for low libido after menopause.

VERDICT: MYTH

A 2019 meta-analysis of 36 randomized controlled trials involving over 8,000 women found clear improvements in sexual desire, arousal, and orgasm. With that level of evidence and prescriptions rising roughly 2.6-fold since 2016, it seems reasonable to assume the FDA has signed off. In September 2026, the agency held its first public workshop on testosterone in menopausal women, which only adds to that impression.

No testosterone product is FDA-approved for use in women. Providers who prescribe it must use a compounding pharmacy, which mixes custom formulations, or prescribe a product approved for men at roughly one-tenth the male dose. The FDA has identified cardiovascular risk, breast cancer, and the absence of safety data beyond 24 months as gaps that must be addressed before any approval.

Every woman currently receiving testosterone is getting it off-label, meaning the drug exists but is not approved for her. Insurance often does not cover it. The September 2026 FDA workshop suggests a regulatory pathway may be forming, but as of October 2026, nothing has been approved.

Official guide

FDA Public Meeting: Testosterone Use In Menopausal Women

U.S. Food and Drug Administration

THE RESEARCH

FDA Public Meeting: Testosterone Use In Menopausal Women

Coalition issues international consensus on testosterone treatment for women (Endocrine Society)

Do Older Women Need Testosterone? (AARP)

THE BOTTOM LINE

Testosterone prescriptions for women have more than doubled, yet the diagnostic tools, the regulatory approval, and the biological rationale behind them are far less settled than the marketing suggests.