On September 17, the FDA is holding a public workshop on testosterone use in menopausal women.
Read that again, because it’s bigger than it sounds.
Back in July I told you I’d come back and go deeper on the foundation itself, on the domains where optimized hormones change the whole health trajectory, and on why “within normal range” and “optimal” are not the same thing. This month the news handed me the perfect way in.

What’s actually happening on September 17

The FDA’s workshop, “Testosterone Use in Menopausal Women,” runs 9:00 a.m. to 4:30 p.m. Eastern, hybrid, in person at the White Oak campus and virtually by Zoom. The stated purpose is to examine the current scientific evidence and the critical knowledge gaps around testosterone use in menopausal women, in order to inform future research and potential drug development.

Look at what’s on the agenda:

• Testosterone physiology across a woman’s lifespan, including age-related decline
• The challenges of measuring and interpreting testosterone blood levels
• How testosterone levels correlate with clinical symptoms
• Current and potential clinical applications in menopausal women
• Regulatory considerations, clinical endpoints, and trial design for long-term safety

That is not a narrow conversation about libido. That is the FDA opening the file on testosterone as a whole-body hormone for women, which is exactly the conversation we have been having in this academy for years.
And here’s the line from the Federal Register notice that I want every provider to sit with: unlike estrogen-containing products, there are no FDA approved indications for testosterone therapy for menopausal women. None. Not one product in this country formulated and dosed for a woman’s physiology. Australia, New Zealand, the United Kingdom, and South Africa have all approved a testosterone product for women with hypoactive sexual desire disorder. The United States has not.

The public comment docket, FDA-2026-N-5479, is open through October 19. More on that in a minute, because you have a role here.

Why this matters, even though we’re already prescribing

For our providers, this isn’t a permission problem. We prescribe testosterone for women off label, thoughtfully and by protocol, because we understand the physiology and we’ve watched what happens when women get it right.
But off label carries a tax, and women pay it. It’s the tax of a colleague raising an eyebrow. Of a pharmacy that hesitates. Of a woman who has to search for someone willing to treat her while her primary care office tells her testosterone is a men’s hormone. An approved, properly dosed product wouldn’t change what we know. It would change how many women can reach it.

So this is a validation moment. The FDA is finally paying attention to something the physiology has pointed to for a long time, and every step like this makes the next clinician a little less reluctant to prescribe.
We’ll be watching what comes out of that room.

A little teaching, because most providers were never taught this

Testosterone is the most abundant biologically active sex steroid in a woman’s body. Not estrogen. Testosterone.
Women make it in the ovaries and adrenal glands, and it declines with age. Not at menopause. With age.
That distinction matters, and a large Australian study published last October made it hard to argue with. Researchers measured androgens by mass spectrometry in 1,104 women aged 40 to 69. Testosterone declined from the early forties to a nadir around age 58 or 59, then rose modestly again. DHEA fell 33% and androstenedione fell 51% across those decades. And in the narrow 48 to 53 age band where the comparison was cleanest, testosterone and DHEA showed no difference at all between premenopausal, perimenopausal, and postmenopausal women. Women who had both ovaries removed sat lower still.

The authors concluded that their data do not support menopause itself as an indication for testosterone. And you know what? On that point, they’re right, and it’s the same thing we teach. Menopause is not an indication. Symptoms plus levels are the indication. A birthday isn’t a diagnosis.

But look at the timing they documented, because that’s what should change how you screen. The decline is well underway in a woman’s forties, years before the hot flashes bring her into your office. If you’re waiting for the menopause transition to start thinking about her androgens, you’re a decade late.
And her receptors don’t stop asking. Androgen receptors sit in the brain, bone, muscle, breast, blood vessels, bladder, skin, and vulvovaginal tissue. That’s not a hormone with one job.

Now, I want to be honest with you about where the evidence stands, because you’ll hear this pushback and you should be ready for it. The strongest randomized trial data for testosterone in women is in sexual function. For bone, muscle, mood, and cognition, the trial evidence is thinner, and serious researchers will tell you so. That’s precisely the gap the FDA has convened this workshop to address, and it’s precisely why the clinical observations coming out of practices like yours matter right now.

This is the symptom picture we teach providers to recognize in a woman with low or suboptimal androgens:

• Fatigue that sleep doesn’t fix
• Aches and joint pain
• Thinning hair and thinning skin
• Low mood, weepiness, loss of motivation
• Poor memory and brain fog
• Vaginal dryness and impaired sexual function
• Low sex drive
• Bone loss

We typically start seeing this picture from the forties onward, and it’s especially common after oophorectomy.
Now look at that list and tell me how many of those women get handed an antidepressant, a sleep aid, and a referral to physical therapy. That’s what happens when a hormone gets filed under “sexual function” and everything else it does gets ignored.

The evidence keeps arriving

Two studies from this year are worth having in your pocket when you walk into a conversation about this.
The first, published in the Journal of Personalized Medicine in April, is a retrospective observational study of 332 women, ages 27 to 78 with a mean age of 45.7, receiving individualized biomarker-guided testosterone therapy through a telehealth platform. The researchers looked at eight symptom domains, not one.

Energy and fatigue improved in 84.3% of women, the strongest response of any domain. Depression, irritability, anhedonia, and sexual interest each exceeded 65% improvement. Cognitive domains improved on a delayed trajectory, with meaningful gains emerging at four to six months. Quality of life improvement was reported by 89.7%, and the share reporting significant improvement climbed from 5.4% at one month to 51.5% past twelve months.

Here’s the finding I want you to hold onto. When women were asked to name where they got the greatest benefit, energy and fatigue came first at 64.2%, mood second at 49.7%, and sexual desire third at 41.3%.
The women themselves ranked energy and mood above libido.

In a subset of 120 women with paired labs at baseline and twelve weeks, the biomarkers moved too, all five favorably: total testosterone up 151.8%, free testosterone up 216.7%, hemoglobin up 5.5%, SHBG down 13.3%, and triglycerides down 12.6%.

Now, I’ll be straight with you about what this is. It’s observational, retrospective, symptom reporting was self-reported at a single point in time, and the cohort skews younger than the menopausal population the FDA is convening about. The authors say plainly that it supports the need for larger controlled trials with extended follow-up. I agree with them. But it is a real signal, in a real clinical population, across the exact domains the FDA has put on its September agenda.
The second is a systematic review published in The Journal of Sexual Medicine in July, covering 33 studies in pre- and postmenopausal women. Its conclusion: testosterone therapy improves sexual function, with the strongest evidence in postmenopausal women, and the premenopausal data still preliminary and in need of better trials.

Put those together and you get the honest state of the science. Strong evidence for sexual function. A growing and compelling signal for energy, mood, cognition, and metabolic markers. And real gaps that only proper trials will close, which is precisely why a workshop on trial design and clinical endpoints is good news.

What we teach at the academy

This is where the training does its work, because knowing testosterone matters for women is not the same as knowing how to replace it in one.

• Dosing forms. For women we teach compounded testosterone in forms designed for female physiology, not a fraction of a men’s product:
  
• Topical cream. A common starting point is testosterone 1.0 to 4.0 mg/mL, applying 0.5 mL (2 clicks) once daily to the inner forearms or inner thighs. It can also be applied vaginally or to the vulvar and clitoral tissue, which is useful when genitourinary symptoms are part of the picture.
  
• Troches. Typically 1.0 to 5.0 mg, often a quarter to a half troche daily.
  
• Subcutaneous injections. For example 25 mg/mL, 0.2 mL weekly, or 0.1 mL twice weekly for steadier levels. Compounded strengths generally range from 12.5 to 100 mg/mL.
  
• Pellets. A typical starting dose is 75 to 87.5 mg every three to four months. Pellets require proper training to prescribe and insert, and we don’t hand that out casually.
  
• Testosterone can be combined with progesterone or DHEA for convenience, and DHEA has its own role, topically at 5 to 20 mg/mL or orally starting at 5 mg.
• Start low, and know your signs of excess. Scalp hair thinning, oily skin or hair, facial or body acne, increased body odor, increased facial hair, and enlarged or darkened clitoral tissue. Start at the low end in any woman with acne or a history of it. Good androgen prescribing in women is a game of inches, not leaps.
  
• Testing, and the difference between normal and optimal
• Here’s where the FDA’s own agenda item on the challenges of measuring and interpreting testosterone levels lands right on top of what we train.

Order a total and free testosterone with SHBG. Not just a total. SHBG is the reason a woman can carry a “normal” total testosterone and still have almost no free hormone available to her tissues, and it’s why women on oral contraceptives so often look and feel androgen deficient on paper and off it. In cycling women, draw sex steroids on day 19, 20, or 21. Add DHT if she has acne, unwanted facial hair, or PCOS/PMOS features.

The ranges we teach for women:

And the timing matters as much as the number. Retest women on injections at three weeks plus three days after the last dose. On pellets, at four to five weeks for peak levels, or ten to twelve weeks for the trough that tells you when to reinsert. On creams, after about three months on a stable dose.

Now the principle underneath all of it, the one I promised you back in July. We aim for the upper quartile, because symptoms live comfortably inside “within normal limits.” A lab range tells you where a population sits. It does not tell you where your patient functions. Labs are the guide. Symptoms lead. A woman whose numbers look fine and who still can’t get off the couch has not been treated, she has been filed.

That is the whole difference between conventional and comprehensive care, and it’s why a hormone can be technically normal and clinically absent at the same time.

Bottom line

The FDA is convening a serious scientific conversation about testosterone in menopausal women, and that is a genuine win for this movement. It won’t change our protocols, because our protocols were built on this physiology and this clinical experience already. It may well change how many women get access to them.

What this means for you:

First, put September 17 on your calendar and watch what comes out of it. Registration and details are on the FDA’s website, and note that in-person registration closes September 10 or when capacity fills. Virtual attendance is open.
Second, and I mean this, consider submitting a public comment to docket FDA-2026-N-5479 before October 19. The FDA is explicitly asking for clinical experience and patient perspective. You have both. The providers doing this work every day have seen things no trial has captured yet. Say what you’ve seen.

Third, look at your own panel this month. Find the women you’re treating with estradiol and progesterone whose energy, mood, and clarity never fully came back. Check a total and free testosterone with SHBG. I suspect you’ll find your answer sitting right there in the “normal” column.

Testosterone is not a men’s hormone that women get a little of. It’s a woman’s hormone that medicine forgot to study, and we are finally watching that get corrected in public.

If you want the full protocols, the dosing forms, the lab interpretation, and the clinical mentorship behind everything in this post, that’s what the BHRT Training Academy was built to give you. Comprehensive, evidence-based, and taught by people who prescribe this every day.

The science is catching up. Let’s make sure the providers are ready when it does.