Testosterone rarely gets equal billing next to estrogen and progesterone in menopause care, but that balance shifted a little when the FDA convened a public workshop dedicated specifically to testosterone therapy in menopausal women. In a post describing the session, Dr. Louise Newson, founder of the UK's Newson Health menopause clinic, called it the agency's first public workshop of its kind. For clinicians who manage perimenopausal and menopausal patients, it's worth unpacking what was actually presented, and what it does and doesn't establish.
What the workshop covered
According to Newson's account, the session included a presentation from Dr. Rachel Rubin, a urologist and sexual medicine specialist, who shared real-world data drawn from the Newson Clinic's own patient population. Newson described the dataset as spanning 18 studies and more than 44,000 patients who have used testosterone through the clinic, a scale that stands out for a therapy that, in the United States, still has no product specifically approved by the FDA for use in women.
That last point matters for how clinicians should read everything that follows. Prescribing testosterone to a female patient in the US remains an off-label decision, typically using formulations approved for men or compounded preparations. A workshop and a dataset can build the case for a future approval pathway; neither one changes the regulatory status on its own.
The claimed benefits go beyond libido
Testosterone's approved and best-studied use in women is for low sexual desire, but Newson's post argued the clinic's data points to a wider set of outcomes: energy, mood, cognition, sleep, motivation, migraines, memory, urinary symptoms, and joint pain. She described these as symptoms “so many women are told to just live with.”
Those are patient- and clinic-reported outcomes from one provider's dataset, not a systematic review, and they haven't been independently verified here. Older, smaller trials have looked at some of these domains with mixed results, which is exactly why a larger real-world dataset in front of regulators is notable, and why it isn't the same thing as a settled indication.
Why prescribing rates stay low
Newson also cited a UK figure: fewer than 1% of women there are currently prescribed testosterone. Low awareness, the absence of an approved product in most markets, and clinicians' understandable caution around off-label hormone therapy all plausibly contribute. Whatever the exact mix of causes, the gap between reported patient benefit and actual prescribing is the crux of why this workshop drew attention in the first place.
What this means for clinicians right now
Treat this as a signal worth tracking, not a change to standard of care. The workshop suggests regulators are taking a closer look at testosterone in menopause, and that real-world data from high-volume prescribers is part of that conversation. Until an approval pathway or updated guidance follows, the practical steps are the familiar ones: discuss off-label status and the current evidence base honestly with patients, document the shared decision, and monitor as you would for any off-label hormone therapy.
This is also a reminder that menopause symptom conversations shouldn't stop at libido. Energy, sleep, mood, and cognitive complaints are common presenting concerns, and they deserve the same structured workup, whatever the eventual role testosterone plays in managing them.
Dr. Newson's full account of the workshop is on her public social media post; the FDA has not, as of this writing, published its own summary of the session.
