Testosterone Therapy for Women: What the Evidence Supports

In the United States there is no testosterone product approved by the FDA for use in women. Every testosterone prescription written for a woman here is off-label, and every compounded testosterone preparation is, by definition, not FDA-approved. That does not make the therapy inappropriate (off-label prescribing is legal, common, and often well-founded), but it does mean the evidence, the dosing, and the monitoring deserve a closer look than this subject usually gets.

This article covers what testosterone therapy in women is actually supported by clinical trial data, what it is not, how dosing and monitoring differ from men, and which side effects matter.

What the evidence supports

The reference document here is the Global Consensus Position Statement on the Use of Testosterone Therapy for Women, published in 2019 and endorsed by a long list of specialty societies, among them the Endocrine Society, the International Menopause Society, the North American Menopause Society, ACOG, and ISSWSH. It was built on a systematic review and meta-analysis of randomized controlled trial data, published the same year in The Lancet Diabetes & Endocrinology.

Its central conclusion is narrow. The only indication for testosterone in women supported by randomized trial evidence is hypoactive sexual desire disorder (HSDD) in postmenopausal women: persistently low sexual desire that causes personal distress, after other contributing causes have been identified and addressed.

For every other proposed use, the statement found the evidence insufficient to recommend testosterone. That list is worth reading closely, because it covers most of the reasons the therapy gets marketed:

• fatigue and low energy
• mood, depression, and general wellbeing
• cognitive function and “brain fog”
• bone density and fracture prevention
• muscle mass, body composition, and athletic performance
• cardiovascular or metabolic health
• use in premenopausal women, for any indication

Insufficient evidence is not the same as evidence of no effect. It means the trials that would settle the question have not been done, or were too small or too short to answer it. Some women do report improvement in these areas. What is missing is trial data showing that testosterone (rather than placebo, or the care and attention that come with starting treatment) is what produced it.

There is no blood test that diagnoses low testosterone in women

This is the point most often gotten wrong, and the consensus statement is unusually direct about it: no blood testosterone concentration has been shown to correlate with symptoms in women. A level in the lower part of the reference range does not diagnose a deficiency, does not predict who will respond to treatment, and should not by itself be the reason to start therapy.

The diagnosis of HSDD is clinical. It is made from symptoms and their effect on the person, after ruling out the other common contributors: relationship factors, depression and anxiety, sleep, medication effects (SSRIs and hormonal contraceptives among them), thyroid disease, pain with intercourse, and vaginal atrophy. Several of those have better-supported treatments than testosterone.

Blood testing still matters, but for a different purpose: a baseline total testosterone establishes the starting point so that treatment can be kept within the physiologic range, and follow-up testing confirms it has not gone above it. The consensus statement also recommends against salivary testosterone testing, which is not reliable for this purpose.

What about premenopausal women?

The consensus statement found insufficient data to recommend testosterone for premenopausal women for any indication, including low desire. The randomized trials were conducted almost entirely in postmenopausal women, and the results do not automatically transfer.

There is a further consideration specific to this group. Testosterone can cause virilization of a female fetus, so it is contraindicated in pregnancy and while breastfeeding, and reliable contraception is a prerequisite for any premenopausal woman who does use it. Prescribers who treat premenopausal patients are working outside the evidence base, which is a decision to make deliberately and with a clear discussion of what is and is not known.

Dosing: women use roughly a tenth of a male dose

The goal of testosterone therapy in women is to restore concentrations to the normal premenopausal physiologic range, not to exceed it. In practice that means doses on the order of one-tenth of what a man on testosterone replacement therapy would receive.

This is where approved male products become a hazard. A testosterone gel packaged for men delivers a dose far above the female physiologic range, and dividing it accurately by eye is not realistic. Supraphysiologic dosing is what drives the serious androgenic side effects described below. It is also the main practical argument for a compounded preparation at a female-appropriate strength, though, as the consensus statement notes, compounded products carry their own trade-off in that their potency and consistency are not verified by a regulator.

Response is not immediate. Trials generally assessed effect at three to six months, and the consensus statement suggests discontinuing if there has been no meaningful benefit by around six months.

Side effects and what is still unknown

At doses that keep concentrations within the female physiologic range, the side effects reported in trials were mostly mild: acne and increased hair growth at the application site or more generally. These are dose-dependent and generally reverse when the dose is lowered or stopped.

At supraphysiologic concentrations the picture changes, and some of these effects may not be reversible:

• deepening of the voice
• clitoral enlargement
• male-pattern scalp hair loss
• more pronounced hirsutism

Route matters for lipids. Oral 17-α-alkylated androgens such as methyltestosterone have been associated with unfavorable effects on cholesterol and with liver enzyme changes; the consensus statement recommends against oral formulations for this reason. Non-oral routes (transdermal, transmucosal, and vaginal) have not shown the same lipid effect in trials.

The larger gap is long-term safety. There are no randomized trials long enough to establish what testosterone does to breast cancer risk or cardiovascular risk in women over years of use. Trials have run months, not decades. Anyone starting this therapy should understand that the long-term safety question is open rather than settled in either direction.

Transfer from topical products

Testosterone applied to the skin can transfer to another person through skin-to-skin contact. In the FDA-approved male products this carries a boxed warning, following reports of virilization in children exposed secondhand: early pubic hair, enlarged genitals, aggressive behavior, advanced bone age.

The doses used in women are much smaller, but the mechanism is the same and the exposed party may be a child. Practical precautions: apply to an area that stays covered, wash hands immediately afterward, let the site dry fully before dressing, and keep the application site covered around children and partners.

Testosterone is a controlled substance

Testosterone is a Schedule III controlled substance in the United States under the Anabolic Steroid Control Act. Three consequences follow for patients:

• A Schedule III prescription may be refilled at most five times, and no more than six months after the date it was written. After that the prescriber must issue a new one.
• Which states a pharmacy may ship a controlled substance to depends on its licensure in each state, and those permissions are narrower than for non-controlled medications. A pharmacy licensed to serve your state for ordinary compounds is not necessarily licensed to send it a controlled substance.
• Verbal and electronic prescribing rules are stricter than for non-controlled drugs.

A compounded testosterone preparation is a controlled substance dispensed only on a prescription written for a named patient, and controlled substances are not shipped to New York addresses.

If you are outside Rhode Island, check the states where Bayview is licensed before assuming a compounded testosterone preparation can be shipped to you.

Forms Bayview compounds

The route is chosen for the clinical situation, not ranked by effectiveness. Transdermal and transmucosal routes avoid first-pass metabolism in the liver; vaginal preparations are generally used to treat local tissue symptoms rather than to raise systemic testosterone.

All of the preparations below are compounded. They are not FDA-approved, and FDA has not evaluated them for safety, effectiveness, or manufacturing quality. Strengths are made to the prescriber's order.

Topical gels and creams

Applied to the skin for systemic absorption, typically once daily. Strength is the critical variable; see the dosing section above. Bayview prepares low-dose testosterone gels and creams for women at the strength the prescriber orders, dispensed with a measured applicator rather than divided by eye.

Vaginal creams and gels

Used for local tissue symptoms (vaginal dryness, discomfort with intercourse, and vulvar pain) rather than for systemic androgen replacement. Testosterone vaginal gel is compounded across a wide strength range. Gabapentin, estriol, and testosterone are also combined in compounded vulvodynia vaginal creams prescribed for vulvodynia and vulvar pain, where the gabapentin component addresses neuropathic pain rather than hormone status.

Vaginal suppositories

The same local indications in a suppository base. An estriol and testosterone vaginal suppository pairs a weak estrogen with a low testosterone dose for genitourinary syndrome of menopause, and compounded vaginal estriol is also prepared without the androgen component. The gabapentin, estriol, and testosterone suppository is the suppository version of the vulvodynia combination.

Troches and oral dissolve tablets

These dissolve against the cheek or under the tongue and absorb through the mucosa, which largely bypasses first-pass liver metabolism, the reason they are not equivalent to a swallowed oral androgen. Available as testosterone troches and as oral dissolve tablets. Female dosing typically requires a fraction of these strengths, so the prescribed strength is made to order.

Slow release capsules and sublingual solution

Testosterone slow release capsules and a testosterone sublingual solution are alternatives where a very small, precisely divided dose is wanted. A solution in particular allows dose adjustment in small increments.

Testosterone is one component of a wider hormone replacement regimen for many patients. Bayview compounds these on a prescriber's order:

• Bi-Est, estriol and estradiol in one preparation, topical or oral
• Micronized progesterone, topical or oral
• DHEA for women, oral, topical, or vaginal

The wider range is searchable: browse all compounded medications Bayview prepares.

Preparations for vulvar, vaginal, and menopausal symptoms sit under the women's health category.

Compounded versus FDA-approved

Compounded preparations are made by a compounding pharmacy for an individual patient on a prescription. They are not reviewed or approved by the FDA, which means the agency has not evaluated their safety, their effectiveness, or the consistency of their manufacture. The 2020 report from the National Academies of Sciences, Engineering, and Medicine on compounded bioidentical hormone therapy reached a similar conclusion and recommended restricting use to patients who cannot use an approved product.

For testosterone in women that framing has an unusual wrinkle: there is no approved product to prefer. The choice is not between a compounded preparation and an approved female one; it is between a compounded preparation at a female-appropriate strength and an approved male product used off-label at a dose it was not designed to deliver. That is a real argument for compounding here, and it is also not a claim that a compounded preparation is safe or effective. Those questions remain open in the same way for both.

Questions people ask

Is there an FDA-approved testosterone product for women in the US?

No. A testosterone patch developed for women was reviewed in 2004 and an FDA advisory committee recommended against approval, citing insufficient long-term safety data. It was later approved in Europe and subsequently withdrawn from that market. Every testosterone prescription for a woman in the US today is off-label.

What is testosterone therapy in women actually used for?

The one indication supported by randomized trial evidence is hypoactive sexual desire disorder in postmenopausal women. Other uses are prescribed, but without trial data behind them.

Can a blood test tell me whether I have low testosterone?

Not in the sense usually meant. No testosterone concentration in women has been shown to correspond to symptoms or to predict response to treatment. Testing is used to establish a baseline and to confirm treatment stays within the physiologic range, not to make the diagnosis.

Does testosterone help with fatigue, mood, or brain fog?

The 2019 consensus review found the evidence insufficient to recommend it for any of these. That is a statement about the absence of adequate trials, not proof that it does nothing, but it does mean anyone offering it for these reasons is going beyond what has been demonstrated.

Can premenopausal women use testosterone therapy?

The evidence does not support it for any indication in this group, and it is contraindicated in pregnancy and breastfeeding because of the risk of virilizing a female fetus. Some prescribers do treat premenopausal patients; that is a decision made outside the evidence base and should be discussed as such.

How much testosterone do women take compared with men?

Roughly a tenth as much. The target is the normal premenopausal physiologic range. Using a male product without accurate dose reduction is the most common route to supraphysiologic levels.

Which side effects are reversible?

Acne and increased hair growth are dose-dependent and generally reverse when the dose is reduced or stopped. Voice deepening, clitoral enlargement, and male-pattern scalp hair loss occur at supraphysiologic levels and may not reverse, which is the practical reason for staying in range and monitoring.

Can testosterone cream transfer to other people?

Yes, through skin contact. Cover the application site, wash hands after applying, and let it dry before dressing. Secondhand exposure has caused virilization in children with the higher-dose male products.

How long before I know whether it is working?

Trials assessed effect at three to six months. If there has been no meaningful benefit by around six months, the consensus statement suggests stopping.

Does insurance cover compounded testosterone?

Usually not. Compounded preparations are frequently excluded from pharmacy benefits, and off-label use of a controlled substance adds a second reason for denial. Ask the pharmacy for the cash price before you assume a copay.

Can Bayview ship testosterone to my state?

It depends on state licensure for controlled substances, which is more restrictive than for ordinary compounded medications. Check the licensed service area or call the pharmacy before your prescriber sends the prescription.

Talking to your prescriber

Useful questions to bring: what specifically are we treating, and is it the indication the evidence supports? What was my baseline level and what range are we aiming for? When will we recheck it? What would make us stop? And have the other contributors (sleep, medications, mood, pain, vaginal atrophy, relationship factors) been addressed first?

Bayview Pharmacy compounds testosterone in the forms above to a prescriber's order as part of its hormone replacement therapy compounding, at strengths appropriate for female dosing, and our pharmacists are available to discuss formulation and route with you or your prescriber. We do not make a determination about whether therapy is right for you; that is a clinical decision between you and the person prescribing.