By Dr. David LaMond, Medical Director Blue Sky MD
The FDA held an important meeting on September 17, 2026, focused specifically on testosterone use in menopausal women. I think this is a very positive development. We need more high-quality research on testosterone in women, particularly around long-term cardiovascular health, breast health, cognition, muscle, bone, mood, sexual function, and overall quality of life. I would also welcome an FDA-approved testosterone product developed specifically for women.
What I think needs to be clarified, however, is the idea that this discussion somehow means testosterone therapy in women is new or poorly studied.
It is neither.
The FDA meeting was really about looking at what we already know, identifying the gaps, and deciding how future studies should be designed. The agency discussed sexual function, cognition, mood, musculoskeletal health, testosterone measurement, cardiovascular outcomes, breast safety, and how future trials should evaluate testosterone in women. You can review the FDA meeting here: FDA Public Meeting on Testosterone Use in Menopausal Women.
My position is straightforward. We absolutely need more research. At the same time, we should not ignore decades of research already sitting in the medical literature.
Testosterone is not simply a male hormone. Women produce testosterone throughout life, although at lower concentrations than men, and it plays a physiologic role in female health. Levels change with age, ovarian function, menopause, medications, SHBG, and other hormonal factors. Clinicians have been studying testosterone therapy in women for decades.
One of the best examples of the size of the existing evidence base is a systematic review and meta-analysis published in The Lancet Diabetes & Endocrinology in 2019. Researchers evaluated 36 randomized controlled trials involving 8,480 women. Testosterone treatment was associated with statistically significant improvements in several measures of sexual function, including desire, arousal, orgasm, sexual satisfaction, responsiveness, and sexual distress. The researchers also appropriately identified areas where additional long-term data were needed.
Eight thousand women in randomized trials is not an absence of evidence.
That distinction matters because I frequently hear testosterone in women described as though physicians are working from a few anecdotal reports. The actual literature is considerably more extensive.
The evidence contributed to the 2019 Global Consensus Position Statement on Testosterone Therapy for Women and the International Society for the Study of Women’s Sexual Health clinical guideline. The strongest guideline-supported indication remains treatment of appropriately selected postmenopausal women with hypoactive sexual desire disorder.
I think that evidence is important, but I also think the clinical conversation is broader than libido.
When a woman in her 40s, 50s, or 60s comes into my office and tells me she no longer feels like herself, I am not looking at testosterone in isolation. I am looking at estrogen, progesterone, testosterone, thyroid function, body composition, muscle mass, sleep, nutrition, insulin resistance, activity level, recovery, mood, cognition, and her overall sense of well-being.
Symptoms overlap tremendously. Fatigue may be related to menopause, sleep, thyroid function, nutrition, iron status, insulin resistance, loss of muscle, or several things occurring at the same time. Difficulty maintaining muscle may relate to protein intake, resistance training, declining estrogen, declining testosterone, thyroid function, aging, or years of chronic calorie restriction.
This is why good hormone medicine cannot simply be about chasing laboratory numbers.
Total testosterone is a good example. A woman may have a total testosterone level appearing relatively normal while the amount actually available to her tissues is quite different because of sex hormone-binding globulin, or SHBG. When SHBG is elevated, more testosterone is bound and less is biologically available.
The laboratory value matters. The patient matters more.
This is also why I welcome research looking beyond libido. Testosterone has biologic relationships with muscle, bone, cognition, energy, sexual function, and other physiologic systems. Some of these relationships are well characterized. Others require better clinical trials before we can say exactly how much benefit testosterone replacement provides.
That is how science progresses.
It does not mean clinicians should pretend the existing physiology and clinical literature do not exist while we wait for the next study.
Testosterone Pellets in Women
Pellet therapy is another area where I think the public conversation often gets ahead of the actual literature.
I have heard it stated repeatedly that there is little or no evidence supporting testosterone pellets in women. That is simply not an accurate description of the medical literature.
There are published studies evaluating subcutaneous testosterone implants in women, including work on symptom improvement, sexual function, pharmacokinetics, serum testosterone levels, breast health, migraine, and long-term clinical outcomes.
Dr. Rebecca Glaser has been one of the most prolific researchers in this area. Her research library at HormoneBalance.org is a useful place for clinicians and patients to begin if they want to see how much published work exists specifically around testosterone therapy and pellet use in women.
For example, a study published in Maturitas evaluated 300 premenopausal and postmenopausal women treated with subcutaneous testosterone implants. Using a validated menopause symptom scale, the investigators reported improvement across psychological, somatic, and urogenital symptoms following therapy.
Another Maturitas study examined testosterone concentrations and pharmacokinetics after subcutaneous testosterone pellet implantation. It demonstrated sustained delivery as well as meaningful individual variation in serum levels, which reinforces why dosing and follow-up need to be individualized rather than treated as a one-size-fits-all protocol.
Dr. Glaser and colleagues have also published long-term observational data involving breast cancer incidence. In a prospective 10-year cohort of 1,267 women treated with testosterone implants, with or without anastrozole, the observed incidence of invasive breast cancer was lower than the age-matched SEER comparison rate.
That study does not prove testosterone prevents breast cancer. It was an observational cohort rather than a randomized controlled trial, and it needs to be interpreted accordingly.
But it is still meaningful clinical evidence and certainly correlates with what I’ve seen in practice for the last twenty years, patients who use testosterone pellets we see have lower incidence of breast cancer when compared to the general population, this includes high risk patients, my women who suffer from obesity. Obesity is the number one risk factor for future risk of breast cancer.
This is an important distinction because medicine does not operate on randomized trials alone. Randomized controlled trials are enormously important, but so are prospective cohorts, observational studies, clinical outcomes, long-term surveillance, and decades of accumulated clinical experience.
At Blue Sky MD, testosterone pellets have been part of our clinical practice for many years, and for appropriately selected women they are often one of my preferred methods of testosterone replacement.
There are practical reasons for this.
Pellets provide sustained hormone delivery over a period of months without asking the patient to apply a medication every day, remember multiple weekly doses, or deal with many of the adherence issues associated with more frequent treatment. Once the pellet is placed, the medication is delivered continuously and the patient can largely get on with her life.
For many women, this simplicity matters.
I also like the consistency we see clinically. Hormone therapy should make a patient’s life easier, not become another complicated daily task she has to manage.
Our experience at Blue Sky MD has been very positive. Appropriately selected women frequently report improvements in sexual health, energy, exercise recovery, strength, body composition, and overall well-being after hormone optimization that includes testosterone when clinically indicated.
Those broader outcomes are part of our clinical experience and are supported to varying degrees by the literature, but not every outcome has been established to the same level in randomized controlled trials. I think it is important to tell patients both what the published evidence proves and what we consistently observe in practice.
I am also comfortable saying that pellets are an established part of our clinical model.
They are not experimental in our practice.
We have twenty years of experience selecting patients, dosing appropriately, monitoring laboratory values and symptoms, and following patients longitudinally. When pellets make sense for a patient, I am comfortable recommending them rather than simply presenting a menu of options and asking the patient to choose without clinical guidance.
That is an important part of medicine. Patients come to us for a recommendation.
There are certainly women for whom another delivery method makes more sense. Pellet therapy is not the correct answer for every patient. However, the fact that pellets are not appropriate for everyone does not diminish their value for the women who are good candidates.
They are also very different from saying pellets lack evidence or clinical experience.
In my view, a more accurate description is that testosterone pellets have a meaningful published evidence base and substantial clinical experience with practical use for more than 50 years, while additional large, long-term comparative studies would make that evidence even stronger.
I would welcome those studies.
Why the FDA Meeting Is Good News
I see the FDA’s renewed attention to testosterone in women as good news for patients and physicians.
Women deserve testosterone products developed specifically for female physiology. They deserve larger long-term studies. They deserve better information about cardiovascular health, breast health, cognition, muscle, bone, sexual function, mood, and quality of life.
I would also like to see more research directly comparing delivery systems, including transdermal therapy, injections, and pellets.
The FDA meeting gives us an opportunity to improve the evidence we already have.
What it should not do is create the impression that we are only now discovering testosterone may have a meaningful role in women’s health.
The science did not begin in 2026.
We already have decades of research, thousands of women studied in randomized trials, international consensus statements, clinical guidelines, prospective cohort studies, pharmacokinetic studies, and specific peer-reviewed research on subcutaneous testosterone pellets.
How I Practice
When I evaluate a woman for hormone therapy, I do not begin with the goal of placing a pellet or raising a testosterone level.
I begin with the patient.
I want to understand what changed. I want to know her symptoms, where she is in menopause, what is happening with estrogen and progesterone, what her testosterone and SHBG look like, what her thyroid is doing, how she is sleeping, how she is exercising, what her body composition looks like, and what she wants to improve.
Then we decide whether hormone therapy makes sense.
When testosterone is clinically appropriate, I am comfortable recommending it. When pellet therapy is the best fit for the patient, I am comfortable recommending pellets along with my clinical team.
I do not think physicians should be afraid to make a clear clinical recommendation simply because a treatment is discussed differently by different professional organizations.
Our responsibility is to understand the literature, understand the limitations of the literature, select patients appropriately, obtain informed consent, monitor treatment carefully, and follow outcomes over time.
That is exactly what we have been doing at Blue Sky MD for decades.
I welcome the FDA’s interest because I think better research will ultimately validate some things we already observe clinically, challenge others, improve dosing, improve patient selection, and hopefully lead to better testosterone options developed specifically for women.
That would be progress.
In the meantime, there is already a substantial body of evidence available to physicians willing to read it.
Women should not have to choose between waiting for perfect data and receiving thoughtful, evidence-informed medical care today.
At Blue Sky MD, we use the evidence we have, remain transparent about what is still being studied, and combine it with nearly two decades of clinical experience to make an individualized recommendation for the patient sitting in front of us.
For many appropriately selected women, testosterone—and specifically pellet therapy—remains a critical part of the conversation.
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