As of October 2026, no testosterone product is FDA-approved for women in the United States. Doctors prescribe it off-label, usually as a reduced dose of a men’s product or a compounded cream or pellet. The best-supported use is low sexual desire that causes distress (hypoactive sexual desire disorder, or HSDD) in postmenopausal women.
Testosterone has been prescribed to women since the late 1930s. Nearly 90 years later, there is still no FDA-approved testosterone product for women in the United States, while men have had approved options for decades. If you’ve been wondering whether testosterone could help with low libido, fatigue, or other midlife symptoms, you’re not alone.
The debate came to a head in fall 2026. The FDA held its first public workshop on testosterone use in menopausal women, and consumer group Public Citizen urged the agency not to approve a product without more evidence, arguing the benefit amounts to “fewer than one additional satisfying sexual event per month.”
So what does the research actually show? A meta-analysis of 36 randomized trials found testosterone improves multiple aspects of sexual function in postmenopausal women, with no serious adverse events recorded. Long-term studies have not found an increase in breast cancer. But important questions remain about heart health and benefits beyond libido. Here’s what you need to know.
What Is Testosterone’s Role in Women?
Testosterone isn’t only a “male” hormone. Women produce it in the ovaries and adrenal glands, at roughly one-tenth of men’s levels. It is best known for its role in sexual desire and arousal.
Women’s testosterone levels change across life:
- During the reproductive years: Levels fall by roughly 25% from the twenties to the forties.
- At natural menopause: There is no sudden drop. Levels continue a gradual, age-related decline.
- After surgical menopause: Removing both ovaries causes a sudden fall in testosterone.
Because testosterone affects desire, energy, and wellbeing, many women and clinicians have turned to it as part of menopause care, even without an FDA-approved product.
Why Is There No FDA-Approved Testosterone for Women?
There is no FDA-approved testosterone for women because no company has yet produced the long-term safety data the agency requires, not because testosterone is new. Doctors have used testosterone pellets in women since the late 1930s, and a 2009 review in the Journal of Sexual Medicine traced its use in women from 1938 onward. Men, by contrast, have had FDA-approved injections, gels and patches for decades.
The closest the U.S. came was in 2004. An FDA advisory committee reviewed a testosterone patch for women with low desire after surgical menopause. The panel voted 14 to 3 that its benefit was clinically meaningful, then voted unanimously against approval because long-term safety had not been established.
So today, U.S. women who use testosterone get it off-label. That usually means a fraction of a men’s product or a compounded cream or pellet. Australia, by contrast, has approved a 1% testosterone cream made for women.
In August 2026, the FDA’s Office of Women’s Health announced a public workshop, held September 17, 2026, on testosterone use in menopausal women. Public comments closed October 19, 2026.
What Did Public Citizen Tell the FDA?
On October 19, 2026, Public Citizen urged the FDA not to approve any testosterone product for women without proof of clinically meaningful benefit and long-term safety data. The comment, written by Dr. Deborah Fadoju of the group’s Health Research Group, went to the docket for the FDA’s September workshop.
Its headline argument: in the 2019 meta-analysis, postmenopausal women on testosterone averaged 0.85 more satisfying sexual events per month than controls. Public Citizen called that “fewer than one additional satisfying sexual event per month.”
Public Citizen asked the FDA to require four things before approval:
- Proof of clinically meaningful benefit for a specific, defined condition
- Long-term safety data, especially for heart disease and breast cancer
- Separate evidence for each proposed use
- Dosing, absorption and monitoring data for each specific product
Why “Less Than One per Month” Is Misleading
That 0.85 figure is an average across women who started from a low baseline. In the APHRODITE trial of 814 women, the best-performing dose added about 2.1 satisfying episodes per four weeks, versus 0.7 on placebo. For a woman starting from roughly two a month, that is a meaningful change.
The same meta-analysis also found improvements in desire, arousal, orgasm, pleasure, responsiveness and self-image, plus less sexual distress and concern. Counting events alone misses most of that. Even the 2004 FDA panel that rejected the patch agreed the benefit was clinically meaningful.
Where Public Citizen Has a Point
Some of Public Citizen’s concerns are fair. In APHRODITE, four women on testosterone were diagnosed with breast cancer, versus none on placebo, though the trial was too small to judge cause. Most randomized trials lasted two years or less and excluded women with higher heart risk. Those are exactly the gaps an FDA-approved product with a proper safety study would close.
What the 2019 Lancet Meta-Analysis Actually Shows
The 2019 meta-analysis by Islam and colleagues, led by Monash University’s Susan Davis, is the strongest evidence on testosterone for women. It pooled 36 blinded, randomized trials with 8,480 participants, each lasting at least 12 weeks, run between 1990 and 2018. The authors also searched unpublished FDA and European regulatory files.
Benefits in Postmenopausal Women
Compared with placebo or a comparator such as estrogen, testosterone significantly improved:
- Satisfying sexual event frequency (about 0.85 more per month)
- Sexual desire, arousal, orgasm and pleasure
- Responsiveness and sexual self-image
- Sexual concerns and sexual distress (both reduced)
Three small trials in premenopausal women showed no benefit. A 2026 Canadian review noted those trials were likely too small to detect one.
Side Effects
No serious adverse events were recorded across the trials. Testosterone did raise the odds of:
- Acne and excess hair growth, the most common side effects
- Weight gain, a small overall increase
- Worse cholesterol with oral testosterone only. Pills raised LDL and lowered HDL. Patches and creams had a neutral lipid effect, which is why the authors recommend non-oral forms.
What It Did Not Find
The meta-analysis found no effect on body composition, muscle and bone measures, or cognition. The authors stressed that few women contributed data on those outcomes, so the question is open rather than closed. Their conclusion: testosterone works for postmenopausal women with low desire causing distress, and its effects on wellbeing, bones, muscle, cognition and long-term safety need more study.
Does Testosterone Help Women With Energy, Mood, Bones, and Joints?
Testosterone may help women beyond libido, but the controlled evidence is still thin, and that is the honest answer. Women’s testosterone falls with age, and many women on therapy report better energy, mood, focus and joint comfort. Rigorous trials have not yet confirmed those effects.
Here’s where the evidence stands today:
- Sexual desire and satisfaction: Proven in randomized trials for postmenopausal women with distressing low desire.
- Mood and brain fog: A 2024 pilot study found improvement in peri- and postmenopausal women already on HRT, but placebo-controlled confirmation is still lacking.
- Bone density: Not shown in the 2019 meta-analysis, though few women contributed data.
- Muscle and body composition: No effect in the meta-analysis, and a review of observational studies found no clear link.
- Joint pain: Small trials have tested testosterone for joint pain caused by breast cancer medications, but it isn’t established for menopause-related aches.
- Energy and wellbeing: Commonly reported by patients in clinics, but not yet proven in controlled trials.
Menopause researcher Susan Davis put it plainly to Live Science: a benefit hasn’t been ruled out, it just hasn’t been shown. The U.K.’s large ESTEEM trial is now testing whether testosterone cream improves quality of life in menopausal women.
This is one more argument for an FDA pathway. Without an approved product, no company has a reason to fund the large trials that could settle these questions.
Does Testosterone Increase Breast Cancer Risk in Women?
Current evidence does not show that testosterone increases breast cancer risk in women, and two long-term studies suggest it may lower it. Both are observational, though, so neither proves protection.
The 10-Year Testosterone Pellet Study (Glaser, 2019)
Surgeon Rebecca Glaser followed 1,267 pre- and postmenopausal women in Dayton, Ohio, who received at least two testosterone pellets. Key findings:
- 11 invasive breast cancers vs. 18 expected, based on age-matched national (SEER) rates
- 165 vs. 271 cases per 100,000 person-years, a 39% lower incidence
- DCIS: 45 vs. 84 expected cases per 100,000 person-years
- Women were treated for an average of 5.3 years; 407 were still on therapy at year 10
- Over 95% used testosterone without systemic estrogen or progestins
- All 11 women diagnosed were alive with no evidence of disease as of March 2018
Other details matter too. About 21% of women also received anastrozole, an estrogen blocker, in their pellets, so the effect of testosterone alone can’t be separated out. Blood testosterone levels averaged 171–490 ng/dL, above the normal female range. Side effects were common: 85% reported a mild-to-moderate increase in facial hair, 6% a severe increase, 11% more acne, and 1% voice changes. There was no randomized control group, and Dr. Glaser holds a patent on testosterone-anastrozole pellets.
The Dutch Transgender Cohort (de Blok, BMJ 2019)
This nationwide study reviewed 1,229 trans men treated with testosterone at Amsterdam’s gender clinic. Only four developed invasive breast cancer, after a median of 15 years of treatment. That is about 80% lower than expected for women (standardized incidence ratio 0.2).
The same study found trans women on estrogen had a 46-fold higher breast cancer risk than men, though still lower than women’s. The authors concluded hormones shift breast cancer risk away from birth sex.
One caveat: many trans men have chest surgery that removes most breast tissue, which lowers breast cancer risk on its own. Trans men also use male-range doses, far higher than women would.
What About Heart Health?
Heart safety is the biggest open question. A 2024 claims study of 16,783 women on testosterone found lower rates of heart events and breast cancer than matched controls. But a study presented at the Menopause Society meeting on October 20, 2026, found heart attack, stroke and heart failure were more common in postmenopausal women prescribed testosterone. That study isn’t peer-reviewed yet, and absolute rates were low. It shows why long-term safety research for women is overdue.
How Many Women Are Prescribed Testosterone?
Very few women receive testosterone, though use is rising fast. A U.S. insurance-claims study found just 4 in every 10,000 women aged 30 and older were prescribed testosterone in 2017, down from a peak of 19 per 10,000. A 2026 study counted more than 90,000 off-label prescriptions to women in 2025, a 58.7% jump from 2024, mostly among women aged 45 to 64.
Why so low? Without an FDA-approved product, there is no women’s dose on a label, no insurer coverage standard, and no official prescribing guidance from the FDA. Many doctors simply aren’t trained to prescribe it. Women are left choosing between a fraction of a men’s gel and a compounded product.
After almost a century of use, the open questions about testosterone for women won’t be answered by avoiding them. An FDA pathway would require exactly the long-term safety and dosing studies that Public Citizen, clinicians, and patients all say are missing.
When Should You Talk to a Provider About Testosterone?
Testosterone isn’t right for every woman, and low libido or fatigue can have many causes. It’s worth a conversation with a healthcare provider if you experience:
- Low sexual desire that causes you distress
- A noticeable drop in libido during perimenopause or after menopause
- Symptoms that continue despite estrogen or other hormone therapy
- Sudden changes after surgical removal of your ovaries
- Persistent fatigue, low mood, or brain fog without a clear cause
A provider can check for other contributors, such as thyroid problems, medications, relationship stress, or depression, before recommending treatment. If testosterone is prescribed, guidelines recommend non-oral forms such as creams or gels, a starting dose of roughly one-tenth of a men’s dose, and regular blood level monitoring.
How Nava Health Helps Women Navigate Testosterone and Hormone Health
For many women, symptoms like exhaustion, low libido, and achy joints aren’t simply a normal part of getting older. They can be signs of hormonal shifts, metabolic changes, or other underlying health concerns that deserve a personalized approach.
At Nava Health, the focus goes beyond symptom management to identify and address root causes. Our medical providers and board-certified nutritionists have over 13 years of experience in hormones and root-cause medicine.
Nava’s discounted intake bundle is $299 and includes:
- 70+ lab tests to assess hormones, metabolism, thyroid function, and more
- 1 hour with a medical provider
- 1 hour with a board-certified nutritionist
Based on your results, your care team develops an individualized plan that may include hormone optimization (when clinically appropriate), nutrition counseling, and ongoing support.
Not sure where to start? Download our free perimenopause checklist to see which symptoms may be hormone-related.
Next step: Book your intake or learn about sexual vitality care for women at Nava.
Frequently Asked Questions
Is testosterone FDA-approved for women?
No. As of October 2026, no testosterone product is FDA-approved for women in the United States. Doctors prescribe it off-label, usually as a reduced dose of a men’s product or a compounded cream or pellet.
What is testosterone used for in women?
The best-supported use is low sexual desire that causes distress (hypoactive sexual desire disorder, or HSDD) in postmenopausal women. Global guidelines from 2019 back this use. Effects on mood, energy, bone and muscle are still being studied.
What are the side effects of testosterone for women?
The most common side effects are acne and unwanted hair growth, plus modest weight gain. Oral testosterone can worsen cholesterol, while skin patches and creams do not. High doses can cause voice changes or hair thinning, so dosing and monitoring matter.
How is testosterone given to women?
Most often as a cream, gel, or skin patch, at about one-tenth of a men’s dose. Pellets implanted under the skin are also used. Oral testosterone is generally avoided because it can worsen cholesterol levels.
Does testosterone cause breast cancer in women?
Current studies do not show an increased risk. A 10-year pellet study found 39% fewer invasive breast cancers than expected, and trans men on testosterone had about 80% lower risk than women. Both studies are observational, so they don’t prove protection.
Is testosterone safe for women’s hearts?
The evidence is mixed. Short-term trials and a 2024 claims study found no increase in heart events. A preliminary October 2026 study found a higher rate of heart events in postmenopausal women on testosterone. Long-term data are still needed.
What did the FDA do about testosterone for women in 2026?
The FDA held a public workshop on testosterone use in menopausal women on September 17, 2026. It collected public comments through October 19, 2026, to inform future research and drug development.
This article is for education only and isn’t medical advice. Talk with a qualified provider before starting any hormone therapy.
Sources
- Islam RM, et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019. doi:10.1016/S2213-8587(19)30189-5
- Glaser RL, et al. Incidence of invasive breast cancer in women treated with testosterone implants: a prospective 10-year cohort study. BMC Cancer. 2019. doi:10.1186/s12885-019-6457-8
- de Blok CJM, et al. Breast cancer risk in transgender people receiving hormone treatment: nationwide cohort study in the Netherlands. BMJ. 2019. doi:10.1136/bmj.l1652
- Public Citizen. Comments regarding the FDA’s public workshop on testosterone use in menopausal women. October 19, 2026.
- U.S. FDA. Public meeting: Testosterone use in menopausal women. September 17, 2026.
- Federal Register. Testosterone use in menopausal women; public workshop; request for comments. August 18, 2026.
- Baillargeon J, et al. Trends in testosterone prescription among women in the USA, 2002–2017. J Gen Intern Med. 2020.
- Live Science. Testosterone for menopause: the treatment is rising in popularity, but does it work?
- HealthDay. Testosterone therapy linked to heart attack, stroke among aging women. October 20, 2026.
- Testosterone therapy in females is not associated with increased cardiovascular or breast cancer risk. J Sex Med. 2024.
- College of Family Physicians of Canada. Tools for Practice #408: Testosterone for women. March 2026.
- Davis SR, et al. Testosterone for low libido in postmenopausal women not taking estrogen (APHRODITE). N Engl J Med. 2008, as summarized by Public Citizen.
