08/22/2026
This is BIG news for women’s health. On September 17, 2026, the FDA is holding a public meeting specifically on TESTOSTERONE USE IN MENOPAUSAL WOMEN.
Read that again, because this has been a long time coming.
Throughout their lives women have produced testosterone. Women have experienced dramatic changes in androgen physiology across aging and menopause. Women have been prescribed testosterone off-label. Other countries have authorized testosterone treatment for women with HSDD. And yet, in the United States, there is still not a single FDA-approved testosterone product specifically formulated and dosed for women.
Unfortunately, that is not changing tomorrow. This meeting is NOT an FDA endorsement of testosterone for menopause. It is NOT an approval. It’s still going to be a long road. But, the conversation has reached the FDA. After the majority of comments regarding the male dosed testosterone discussion at the FDA last year being from women asking for consideration, this discussion is moving forward!
Let’s look at what they actually intend to discuss. The FDA says the meeting will examine testosterone physiology across a woman’s lifespan, the challenges of measuring and interpreting testosterone blood levels, and the evidence surrounding testosterone and:
• sexual function
• cognition
• mood and depressive symptoms
• sleep
• frailty
• musculoskeletal health
• cardiovascular safety
• breast safety
Do you see it is NOT just hypoactive sexual desire disorder?!? Big big big!
They continue that the meeting is intended to help “inform future research and potential drug development of testosterone products for menopausal women.” Potential. Drug. Development.
They will even discuss what evidence, clinical endpoints, trial designs, and safety data would be necessary to support a future marketing application for testosterone in menopausal women. That is HUGE.
One of the strangest problems in women’s health is this crazy circle. There is no FDA-approved testosterone product for women → clinicians are reluctant to prescribe testosterone because there is no FDA-approved product → women who do receive it often use compounded testosterone or tiny fractions of products manufactured for men → standardized female dosing and large-scale outcome data remain limited → and the lack of evidence and approved products is then used to justify continued reluctance. Lather, rinse, repeat.
At some point, the FDA needs to clarify what research would actually allow us to move forward? The FDA is now formally asking that question.
I am VERY interested in their decision to include testosterone measurement and interpretation, because this desperately needs attention.
What does a serum testosterone number actually tell us about androgen activity in an individual woman? How should total testosterone, free testosterone, and SHBG be interpreted? How reliable are assays at the concentrations typically seen in women? What levels correlate with symptoms, benefits or adverse effects? Should laboratory reference ranges become treatment targets vs age related norms? What outcomes should we actually be measuring?
I’m also thrilled that the discussion isn’t being restricted entirely to libido. Finally. Hallelujah. Sexual function matters enormously and should never be minimized. HSDD is also where we currently have the strongest evidence for testosterone therapy in postmenopausal women. But women have been asking questions about muscle, bone, frailty, cognition, mood, sleep and metabolic health for a very long time. But the most common pathway to testosterone options is through the one portal that also affects men enormously. It might be coincidental, but it’s time to look at the whole woman.
The correct response to insufficient evidence isn’t to pretend those questions don’t exist. LET’S DO THE RESEARCH.
There is another opportunity here that I hope women’s-health clinicians, researchers and advocates (US!) take very seriously. The FDA has opened a public docket for comments, evidence and data, and the agency specifically says that patient perspectives will be explored.
That means this conversation doesn’t have to happen about menopausal women without menopausal women. We can share our experiences, thoughts, stories, etc. This is our moment. I am not including the link in the post, because…algorithms. I might add it in the comments (I’m not sure how much that affects this.). But I ask you to take a second to look for the link understanding I am prioritizing as many women as possible see this opportunity.
Again, none of this tells us what the FDA will ultimately conclude. But after watching women use a hormone their own bodies produce through products designed for men, while dealing with the attitude that absence of an FDA-approved female product is evidence that their treatment is somehow illegitimate…I find this incredibly encouraging.
This isn’t approval, but it’s an important step forward and if’s coming SOON.
September 17.
I’ll be watching. Very, very closely.
