There is no FDA-approved testosterone product for women in the US. Doctors who prescribe it use male products off-label or order a compounded preparation. The 2019 Global Consensus Position Statement supports testosterone for one use: postmenopausal women diagnosed with hypoactive sexual desire disorder (HSDD), at doses that keep levels in the normal female range. A compounding pharmacy can prepare a prescribed dose in a suitable base. Your prescriber manages dosing and monitoring.
About one in three women at midlife lives with low sexual desire that causes her real distress. When 11 medical societies issued joint guidance on testosterone therapy for women in 2019, The Endocrine Society estimated that hypoactive sexual desire disorder affects roughly 32% of women around midlife. Yet the United States still has no testosterone product approved by the FDA for women.
Demand is not waiting for an approval. According to Reuters reporting on Truveta data, the rate of testosterone prescriptions for women rose 146% between January 2023 and July 2026. Access is still uneven, and many women run into pharmacy denials, delays, and limited insurance coverage.
Below, we cover why options are limited, what the evidence supports, where a compounding pharmacy fits, and why your prescriber stays at the center.
Why Testosterone Therapy for Women Is So Hard to Find in the US
The testosterone gels, creams, and patches approved in the US are made and dosed for men. When a doctor prescribes testosterone to a woman, it is off-label use. That means the prescriber has to work out a much smaller dose than any approved product was designed to deliver.
A Product Gap, Not a Prescribing Ban
Off-label prescribing is legal. Mayo Clinic notes that US regulators have not approved testosterone for women, though doctors may still prescribe it.
Testosterone products have been approved for HSDD in places such as Australia and the UK, according to a Holland & Knight summary of the recent FDA workshop.
What Off-Label Use Looks Like Day to Day
In practice, off-label use often means dividing a product built for a man into very small portions, which is hard to do accurately at home.
Getting the prescription filled can be its own hurdle. Reuters reported that some large pharmacies decline testosterone prescriptions that require dose customization and that insurance coverage is often limited.
Regulators Are Paying Attention
The FDA is actively reviewing this question. On September 17, 2026, the agency held a public workshop on testosterone use in menopausal women, noting growing off-label use, with a public comment period running through October 19, 2026. FDA identified dosing and long-term cardiovascular and breast safety as key gaps in what is known.
No testosterone product for women has been approved so far, and guidance may change as the review continues. Ask your prescriber about the most current recommendations before you start or change any therapy.
What the Global Consensus Says About Testosterone for Women
In 2019, 11 international medical societies, including The Endocrine Society and the North American Menopause Society (now The Menopause Society), agreed on one evidence-based use for testosterone in women. That use is treating postmenopausal women diagnosed with HSDD after a full biopsychosocial assessment.
That Global Consensus Position Statement is still the clearest guide to what the research supports.
The One Indication and What the Benefit Looks Like
For postmenopausal women with HSDD, the consensus found that testosterone produced moderate improvements in desire, arousal, orgasm, and pleasure, along with less distress about sex. On average, women in the trials reported about one additional satisfying sexual event per month compared with placebo.
That may sound small, but for a woman who has felt disconnected from that part of her life, it can matter. Modest, but real.
What It Is Not For
The statement found no proven benefit from testosterone for mood, energy, cognition, bone health, or muscle.
It also found too little data to recommend testosterone for premenopausal women. If you are in perimenopause, your symptoms still matter; the research simply has not caught up, and your doctor can discuss better-studied options.
How the Statement Treats Formulations
The consensus favors transdermal testosterone (applied to the skin) at doses that keep blood levels within the normal premenopausal female range. It does not recommend oral testosterone, injections, or pellets, partly because some of these can push levels well above that range.
On compounding, the statement is cautious. It does not generally recommend compounded testosterone. It makes one exception: where no approved female product exists, a quality-assured compounded product kept within physiologic doses may be considered.
The US currently falls into that situation. Even so, presenters at the FDA workshop raised concerns about the dose reliability of compounded products and the lack of a formal adverse-event reporting system for them. Medical societies do not endorse compounded testosterone, and you deserve to know that.
Where a Compounding Pharmacy Fits in Testosterone Therapy for Women
When a prescriber decides testosterone is appropriate, a compounding pharmacy can prepare the exact strength they order in a cream or gel base suited to a woman’s dose. As the FDA’s consumer information on compounding explains, compounded medications are not FDA-approved and do not go through premarket review.
As a compounding pharmacy in Irvine, King’s Pharmacy can work with your prescriber when testosterone is part of the plan.
Dose-Appropriate Strengths
Your prescriber chooses the strength, and the pharmacy prepares it consistently, fill after fill. The advantage over dividing a male product is accuracy, not potency.
Bases Built Around the Patient
Some women react to dyes, fragrances, or particular inactive ingredients, and the FDA recognizes allergy-related needs, such as a dye-free version, as an appropriate reason to compound. Testosterone for women is usually prepared as a topical cream or gel, and the exact format depends on what your prescriber orders.
Fitting Into a Broader Bioidentical Hormone Replacement Therapy Plan
Most women in the testosterone trials were also using estrogen. A compounding pharmacy can coordinate with your prescriber across the whole regimen.
If you are weighing bioidentical hormone replacement therapy more broadly, our menopause guide to bioidentical hormones covers the bigger picture. You can also learn more about our women’s hormone health services.
Quality Questions Worth Asking Any Compounding Pharmacy
The consensus statement’s exception for compounded testosterone rests on two conditions: pharmaceutical-grade ingredients and good manufacturing standards. The FDA warns that poorly compounded medications can have the wrong strength or be contaminated, which matters with a hormone that must stay in a narrow range.
So ask questions. Start with where the pharmacy sources its active ingredients and whether they are pharmaceutical grade. Then ask how it checks the strength and consistency of what it prepares and which quality standards guide its work.
Ask whether the pharmacy is licensed in your state, since a pharmacy needs a license where it dispenses. King’s is NABP accredited, based in California and licensed in several states beyond California; contact the pharmacy to confirm yours. Finally, ask whether a pharmacist will take time to talk with you about your prescription. A good pharmacy will welcome these questions.
“The right compounded testosterone isn’t the strongest one. It’s the one that keeps you in a woman’s natural range.”
Safety and Monitoring: Why Testosterone Therapy for Women Needs a Prescriber
Testosterone therapy for women should begin with a proper evaluation and continue with follow-up blood work. Your prescriber decides whether it is right for you, sets the dose, and watches for side effects. A pharmacy cannot do that for you.
What Monitoring Involves, in General Terms
The consensus statement describes a monitoring approach your doctor may follow. It includes a baseline testosterone level before starting, a recheck within the first several weeks, and periodic checks after that. It also suggests stopping if there is no meaningful benefit by around six months, though your prescriber will tailor the plan to you.
Side Effects and Who Should Be Cautious
Mayo Clinic lists possible side effects that include acne, unwanted facial or body hair, scalp hair loss, and weight gain. It also notes that testosterone is not appropriate for women with heart, blood vessel, or liver disease, or with a history of breast or uterine cancer.
In short-term studies at physiologic doses, the consensus found no serious adverse events in postmenopausal women. Safety beyond about two years has not been established, and long-term heart and breast effects remain open questions.
Why Blood Levels Are Not a Diagnosis
The consensus statement says a testosterone level should not be used to diagnose HSDD. Low desire has many possible causes, from stress and sleep to medications and relationships, so a clinician looks at the whole picture.
Taking the Next Step With Your Doctor and King’s Pharmacy
Your first conversation belongs with a clinician who knows your health history. That might be your OB-GYN, a menopause specialist, or one of the functional medicine providers who look at hormones in the context of your overall health.
Come prepared to describe your symptoms, how long the low desire has lasted, and how much it bothers you, plus any medications, supplements, or hormones you take. Ask about current guidance too, since the FDA’s review is still underway.
If your prescriber decides compounded testosterone is appropriate, they can send the prescription to King’s. Every compounded medication requires a valid prescription. You can read about how we partner with prescribers. King’s is contracted with nearly all insurance plans and helps doctor offices with insurance troubleshooting, though coverage for testosterone varies and is never guaranteed.
The Bottom Line
Roughly a third of women at midlife are affected by HSDD, and the US still has no testosterone product approved for them. Testosterone has a narrow but genuine role for postmenopausal women with HSDD, at doses that keep levels in a woman’s natural range.
For women whose prescriber recommends it, quality compounding can provide a dose made for a woman rather than a fraction of a man’s. The decision, the dose, and the monitoring stay with your doctor.
Medical disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Compounded medications require a valid prescription. Talk with your healthcare provider about your individual situation.
Have questions about whether a compounded medication is right for you? Talk to your prescribing physician, then connect with the pharmacists at King’s Pharmacy and Compounding Center in Irvine, CA, to get started.
Request a Refill or Contact King’s Pharmacy at 949.387.0780.
Frequently Asked Questions
Is there an FDA-approved testosterone product for women?
No. There is currently no FDA-approved testosterone product for women in the US, so doctors who prescribe it use male products off-label or order a compounded preparation. The FDA is actively reviewing the topic, so ask your prescriber about current guidance.
Can testosterone help with low libido after menopause?
For postmenopausal women diagnosed with hypoactive sexual desire disorder, the 2019 Global Consensus Position Statement found that testosterone can moderately improve desire, arousal, and sexual satisfaction. The benefit is modest, about one additional satisfying sexual event per month on average compared with placebo.
Is compounded testosterone safe for women?
Compounded medications are not FDA-approved, and the 2019 consensus statement does not generally recommend compounded testosterone. It allows that a quality-assured compounded product kept within physiologic female doses may be considered where no approved female product exists, as in the US. Safety depends on pharmacy quality, appropriate prescribing, and regular monitoring by your doctor.
Can women in perimenopause use testosterone therapy?
The 2019 consensus statement found insufficient data to recommend testosterone for premenopausal women, a group that includes many women in perimenopause. Your doctor can discuss options better studied for your stage of life.
Do I need a prescription for compounded testosterone cream?
Yes. Every compounded medication, including compounded testosterone cream, requires a valid prescription from a licensed prescriber, and testosterone is also a controlled substance. Your prescriber decides whether it is appropriate, sets the strength, and oversees monitoring.
