For decades, the question about testosterone in women was whether it mattered at all. That question is closed. The real question is why the FDA has approved roughly thirty-one testosterone products for men and exactly zero for women.
I put that question to Dr. Susan Hardwick-Smith, an OB-GYN who spent eighteen years building one of the largest OB-GYN practices in her city, then walked away from it in 2020 to build a menopause practice from scratch. The reason was personal. She went through menopause herself and realized that thirty years in women’s health had not taught her a thing about how to treat it. Testosterone was the biggest gap. Like most of us trained in traditional medicine, she had only ever seen testosterone in women framed as pathology: polycystic ovary syndrome, an androgen-producing tumor. Never as a hormone every woman’s body makes, and every woman’s body eventually loses, as a normal part of aging.
I want you to sit with that for a second. This is not a rare condition. It happens to every woman who lives long enough, and medicine still has not built the infrastructure to treat it.
Here are five things I want cleared up.
Myth 1: Testosterone is a male hormone that women happen to carry
It is not. Gram for gram, women make far more testosterone than estrogen. Dr. Hardwick-Smith put it simply: if your estradiol reads fifty on a lab report, your testosterone would read closer to five hundred once you convert the units to compare them side by side. It comes from the ovaries, the adrenal glands, and peripheral tissue.
Here is what almost nobody gets taught. Estrogen and progesterone drop off sharply once the ovaries shut down at menopause. Testosterone does not follow the same schedule. Some production continues after menopause, just at a much lower level, and for a large share of women it starts declining years before a period ever gets missed. Dr. Hardwick-Smith sees patients in their early forties, still cycling on a normal schedule, already presenting with classic low testosterone symptoms. Her own testosterone was undetectable at forty-five.
The symptom list should sound familiar, because it is nearly identical to what shows up in men with low testosterone: low sex drive, difficulty reaching orgasm, low energy, fat gain around the midsection, brain fog, trouble finding words, anxiety, depression. And the sexual symptoms go beyond desire. Blood flow to the clitoris runs on the same basic vascular mechanism as an erection, so a woman losing testosterone can lose a piece of sexual function that has nothing to do with wanting sex in the first place.
Ask her what surprised her most in the literature and she gives you four answers.
Cognition and mood. A 2024 study by Dr. Louise Newson looked specifically at testosterone’s cognitive effects, and it lines up with what she hears from patients every week: less anxiety, sharper recall, less brain fog, and a return of drive that has nothing to do with the bedroom. Separately, newer research in APOE4 carriers has linked lower endogenous testosterone to a higher rate of Alzheimer’s disease and worse cognitive testing in those who carry the gene. That is an association, not a proven mechanism, and I want to be exact about that distinction rather than round it up into something it is not.
Breast cancer. The data consistently points toward a lower incidence of breast cancer with testosterone use, and nothing in the literature points the other direction. That is a pattern worth taking seriously. It is not a settled causal claim, and neither of us is going to pretend it is.
Muscle and bone. This is the one with the least argument attached to it. Testosterone slows muscle loss, supports the ability to build new muscle, and supports bone density, which means it sits directly upstream of fall risk, frailty, and how long a woman keeps her independence.
Genitourinary tissue and joints. Improvements in vaginal and urinary tissue health, and in more recent reading, a possible benefit for osteoarthritis, likely running through the same anti-inflammatory pathway that gives estrogen its benefit in frozen shoulder and plantar fasciitis.
Myth 2: No FDA approval means there is no real option
This did not happen because nobody studied the hormone. It happened because of regulatory history, and the history explains why so many women get told there is nothing to be done.
In 2004, Procter & Gamble brought a low dose testosterone patch called Intrinsa to the FDA. It delivered 300 micrograms a day, and the trial data behind it was solid. That same 300 mcg dose has since been used in at least six randomized controlled trials for hypoactive sexual desire disorder, with meaningful benefit shown across every one of them. The FDA said no. Timing mattered here. This was about eighteen months after the Women’s Health Initiative had convinced a generation of doctors and patients that hormone therapy was dangerous across the board. In that climate, the FDA asked for five more years of cardiovascular data, an estimated $300 million ask. Procter & Gamble walked away rather than pay it. A few years later a testosterone gel called LibiGel failed the same test, and the company behind it, BioSante, went out of business.
Now put that next to what happened with testosterone for men over the same period. A black box warning about possible cardiovascular risk went through to approval anyway, with the drug simply carrying the label. That warning was not removed until the TRAVERSE trial cleared it last year. So the same regulatory system approved a product for men while flagging a risk that was never proven, and buried a product for women that had the trial data behind it.
There is a structural reason nobody has tried again. Testosterone is bioidentical. It is chemically the same molecule your body already makes, which means it cannot be patented. The only patentable piece is the delivery device, and after two expensive public failures, no pharmaceutical company wants to fund what a third attempt would cost. Dr. Hardwick-Smith’s read, and I share it, is that we are not getting an FDA-approved product for women anytime soon.
None of that means testosterone cannot be prescribed. Off-label prescribing is a normal, routine part of medicine, and FDA approval, while valuable when you have it, was never a requirement for a treatment to be appropriate. Every FDA-approved drug on the market carries its own list of side effects. Approval means a body of safety data exists. It does not mean the absence of risk. And defaulting to “there is nothing we can do” has a real cost. Estrogen itself is only FDA-labeled for a handful of things: osteoporosis prevention, hot flashes, genitourinary symptoms, despite an evidence base for benefit that runs far wider than that, because a label only reflects what a trial happened to measure. No label is not the same thing as no evidence.
Myth 3: Testosterone therapy will make you lose your hair and grow a beard
This fear did not come from nowhere. It is just aimed at the wrong variable. The variable that matters is dose, not the hormone itself.
Start with the safety data, because it is stronger than most clinicians realize. Dr. Hardwick-Smith points to transgender men, who take far higher doses of testosterone than any protocol used in cisgender women, for years to decades, and who have been followed in long term studies, including a fifty year dataset out of Amsterdam and multiple studies from Japan spanning ten to twenty years. Across that body of work: no increase in mortality, real improvements in muscle and bone mass, and red blood cell increases that stayed minor and never turned into a clinical problem. Separately, large NHANES-based studies tracking roughly a decade of data found no increase in major cardiac events tied to testosterone in women, with a drop in pulmonary embolism and heart attack in women under fifty and no change in women over fifty.
Oral testosterone is the one real exception. Taken by mouth, it raises LDL and lowers HDL, which is exactly why nobody uses it that way anymore. Pellets, injections, and transdermal delivery do not carry that risk.
The side effects that do show up with too much testosterone, unwanted facial hair, hair thinning, acne, a deepening voice, are real, but they are dose dependent, slow to build, and reversible if you catch them early. Dr. Hardwick-Smith described a patient on high dose pellet therapy for eight straight years, with blood levels sitting around 800 ng/dL, who developed significant hair loss only after all that time. The dose did that. Not the hormone. And it took eight years of sustained overexposure, not eight weeks.
Her line, and I am borrowing it because it is exactly right, is that dose is the poison. Almost nothing in medicine is safe at every dose, and almost nothing with a real benefit comes without a possible downside somewhere. The job is finding the right amount for that specific patient, not avoiding the hormone altogether.
Myth 4: Any testosterone gel works, and the lab number tells the whole story
In 2019, a group of international experts published a consensus statement on testosterone use in women. Dr. Hardwick-Smith respects the intent behind it and is blunt about the result. Get fifteen or sixteen experts trying to agree on anything and you end up with something watered down, and what they landed on recommends a delivery method that does not hold up in practice.
The consensus tells clinicians to take a men’s FDA-approved testosterone gel and use roughly a tenth of the standard male dose, aiming for a target range around 50 to 70 ng/dL. Walk through why that fails. Dividing a gel tube into precise tenths is not something you can do with any accuracy. In her words, it becomes a big blob or a little blob. More importantly, topical gel is dosed ten times higher than other delivery methods for a reason: skin absorption is unpredictable, and that is well documented in the male urology literature already. Studies comparing two FDA-approved men’s gels, AndroGel and Testim, found dramatically different blood levels between them. Some men barely absorbed any of the dose. Others absorbed far more than intended. If that inconsistency shows up in men, there is no reason to expect gel to behave any better in women.
Her clinic ran the comparison directly. Patients starting under 20 ng/dL were split between 5 mg a day of gel or an appropriately dosed pellet, then retested at six weeks. The pellet group averaged 92 ng/dL. The gel group averaged 132 ng/dL, but the individual results swung from one extreme to the other. Some patients barely absorbed anything. Others blew past the consensus’s own target range. Pellets and injections sit under the skin instead of going through it, so nothing evaporates off before it gets absorbed, which is exactly why they land in a tighter, more predictable range.
Pellets carry a reputation they have not earned. Testosterone pellets have been FDA-approved for men, under the name Testopel, since the 1970s. The bad reputation traces back to a specific dosing protocol taught starting around 2011 by a company called BioTE, which sent clinicians, some with no endocrinology background at all, through a single weekend course and told them to target blood levels of 250 to 350 ng/dL in women. That protocol is what caused the hair loss case above. It is proof that one regimen was dosed too high. It is not proof that pellets themselves are a problem. BioTE’s founder, Gary Donovitz, separately published safety data on more than a million pellets with no major safety signal, though Dr. Hardwick-Smith still disagrees with the dose he was teaching.
Her own protocol, which she has used on herself for eight years without a single side effect, is 0.8 to 1 mg of testosterone per kilogram of body weight, delivered as a pellet that lasts roughly three months, with blood work at six weeks and then every six months after that. In her practice, that lands most patients comfortably in the 50 to 120 ng/dL range: well above the consensus’s narrow target, far below anything associated with side effects, and roughly what a healthy woman in her twenties carries.
On the number itself, a few things worth knowing. Track total testosterone, not free testosterone. Free testosterone, as reported by nearly every commercial lab, is not a direct measurement at all. It is calculated from total testosterone and SHBG using a formula, and the international consensus itself says not to rely on it in women, because a true direct measurement requires a method almost no lab runs. Standard testing is good enough to make decisions on. Her clinic ran a same day comparison on 99 women through Baylor, testing both the standard method and the more precise LC-MS method, and the difference was too small to change a single treatment decision: about 6 ng/dL apart in women not on testosterone, about 22 ng/dL apart in women on therapy. A blood level is a guide, not a verdict. It shifts within the same day and does not fully capture what is happening at the tissue level. The number that matters most is how the patient feels without side effects, not a specific value on a printout.
And more is not better, full stop. Push testosterone high enough and you stop getting more benefit. You get tachyphylaxis instead. The receptors saturate, downregulate, and the treatment quietly stops working the way it did, which is exactly what pushes people toward chasing bigger and bigger doses for a smaller and smaller return. This is not a substance to chase a high on. The goal is feeling like yourself again, not feeling something extra.
Myth 5: If your levels are low, diet and supplements can fix it
Dr. Hardwick-Smith tried. In her own words: yoga, meditation, clean eating, sheer will. Her testosterone stayed at zero the entire time. She also tried the one supplement with any real signal behind it, DHEA, at 100 mg a day for six weeks. Her testosterone moved from 0 to 40 ng/dL, a real number on paper, but not enough to change a single thing about how she felt. The DHEA research backs that up. It does not reliably push levels high enough to meaningfully help symptoms like low sex drive. As of right now, there is no supplement and no lifestyle change with evidence behind it that restores testosterone to a level that changes how a woman feels once her own production has dropped.
Two categories of medication are worth naming if the symptoms and the labs are not matching up. Oral contraceptives shut down ovulation, which cuts off roughly half of a woman’s testosterone supply at the source, and they raise SHBG on top of that, binding up whatever testosterone is left so it cannot be used. Androgen blocking drugs like spironolactone and finasteride limit how much testosterone reaches the receptor in the first place. Neither one makes testosterone therapy wrong for that patient. They are simply variables to account for when the numbers and the symptoms do not line up.
Where this leaves you
There is no FDA-approved testosterone product for women, and the reason is money and regulatory history, not science. A patch with strong trial data behind it got turned away in 2004, in the middle of a hormone panic, and no company has funded another attempt since. That gap pushed the field toward a consensus built on a delivery method that, by Dr. Hardwick-Smith’s own clinic data, does not reliably work.
Here is what does hold up. Testosterone plays a real, measurable role in sexual function, mood, cognition, muscle, and bone in women. The long term safety data, built on decades of far higher doses in transgender medicine, is reassuring. The real risk sits almost entirely in dosing too high for too long, not in using testosterone at all. Dosed properly and monitored consistently, most patients see real benefit, with side effects that are minor and reversible if they show up at all.
If you are working through this for yourself: ask what delivery method your provider is using and why. Ask what target range they are working toward. Expect blood work at six weeks, then every six months after that. Do not accept a prescription and a “see you next year.”
Stay Forever Strong.
Dr. Gabrielle Lyon
This content is for general educational purposes based on a conversation with Dr. Susan Hardwick-Smith and is not a substitute for individualized medical advice. Testosterone therapy requires evaluation, dosing, and monitoring by a qualified physician.
