American women are still being prescribed testosterone as if we were small men. For 30 years, I have prescribed testosterone to women off-label, meaning for a use that is not specifically approved by the FDA. The testosterone prescription usually requires either a compounding pharmacy to prepare a physiologic dose for a woman or the careful fractionation of a male-approved product, dispensing only a small portion of the dose designed for men, usually one tenth or so.
Why am I stuck doing this, and more importantly, why are American women forced to pay too much for testosterone, since it’s not covered by insurance? It’s not because testosterone is experimental, and it’s definitely not because women do not benefit from it… we know that many women do benefit, but not all.
I do it because the United States has never approved a testosterone product made specifically for women, yet four other countries have. This situation must change.
Australia approved a physiologically dosed transdermal cream for women in 2020. New Zealand and South Africa followed. In July 2025, the United Kingdom approved it too. [1]
Women in all four countries can now fill a prescription for testosterone formulated for their bodies, rather than trying to divide a product designed for a man, or paying out of pocket for a compounding pharmacy to the tune of hundreds of dollars per month. American women are still improvising and becoming increasingly frustrated. I get it. There’s a surge in off-label use of testosterone over the past few years.
Yesterday, the FDA held the most consequential public discussion of testosterone therapy for women in years. [2] What emerged was larger than a debate about libido, it exposed a familiar failure in women’s medicine: when the evidence, the regulatory system, and women’s lived experience do not move at the same speed, women are left to absorb the uncertainty.
Here is what the FDA reviewed, what the evidence shows, and what every woman considering testosterone deserves to know, from dosing to labs and how I monitor for safety. The full testosterone protocol for women.
