The FDA Is Finally Asking About Testosterone for Women. Here Is What I Want Them to Hear.

You asked your doctor about testosterone and got a look. Maybe a laugh. Maybe the line I hear most often from women who come to me after two or three other providers: "That's a male hormone. You don't need it."

You do. Women make testosterone their entire lives, and it matters for desire, energy, muscle, bone, and mood. But for more than twenty years, the FDA has not approved a single testosterone product for women in the United States. Men have many options. Women have none.

On September 17, 2026, that finally started to change. The FDA held its first public workshop on testosterone for menopausal women in two decades, and it opened a public comment period that closes October 19, 2026.[1][2] Here is what happened, what the evidence actually shows, what I want the FDA to hear, and how you can make your voice part of the record.

What Happened at the FDA on September 17

The FDA's Office of Women's Health and its Center for Drug Evaluation and Research co-hosted the workshop. Endocrinologists, gynecologists, urologists, FDA medical officers, and women who use testosterone all spoke. By the time it ended, more than 1,320 public comments had already been submitted.[4]

The headline is the tone. The FDA said it stands ready to talk with drug companies and wants to bring these products to American women. It closed with a line I never expected to hear from the agency: menopause is inevitable, but women should not have to suffer.[4]

The FDA also named what it needs before it can approve anything:[4]

• Cardiovascular safety data. Existing studies are too short and too often not randomized.
• Breast cancer data. The evidence is mixed, with some signals of risk and some of protection.
• Long-term safety beyond 24 months. Most trials stop at two years.
• Better dosing research. The lowest effective dose, the right patients, and the best delivery method.
• Outcomes women care about. The agency asked what counts as a meaningful improvement to patients, not only to researchers.

Why There Is Still No FDA-Approved Testosterone for Women

The last time the FDA seriously looked at this was 2004, when an advisory committee reviewed Intrinsa, a testosterone patch for women with low desire after surgical menopause. It was not approved in the United States. Nothing has replaced it since.[5]

Meanwhile, testosterone is approved for low sexual desire in postmenopausal women in Australia, New Zealand, the United Kingdom, and South Africa.[4] American women are not biologically different. They have simply been left out.

So women here have been getting testosterone the only ways available: male products used off-label at a fraction of the dose, or compounded creams, gels, and pellets. Off-label prescribing to women near or past menopause has tripled in five years. Even so, fewer than 0.36% of menopausal women are prescribed it.[4]

That is the gap: a real need, a growing number of women using testosterone anyway, and no product designed, dosed, or labeled for them.

What the Evidence Shows, Honestly

I have written about what testosterone does for women after 40. I stand by it. I also want to be precise about where the evidence is strong and where it is still catching up, because that precision is what will get testosterone approved.

Strong evidence: low sexual desire. The 2019 Global Consensus Position Statement, endorsed by 11 medical societies, concluded that the evidence-based use of testosterone in women is for hypoactive sexual desire disorder (HSDD) in postmenopausal women, at physiologic doses.[4]

Promising but under-studied: everything else. Energy, mood, mental clarity, muscle, and bone. Many clinicians, including me, see real improvement in these areas when testosterone is added to estrogen and progesterone. Workshop presenters were clear that the controlled trials for these uses have not been done yet.[4] Not done is different from disproven.

Three facts that surprise most women:

1. Testosterone declines gradually with age, not suddenly at menopause. The exception is surgical menopause, where removing the ovaries cuts testosterone sharply.[4]
2. Standard lab tests are poor at measuring testosterone in women. Most assays were designed for male levels and lose accuracy at the low concentrations women have.[4]
3. More is not better. The FDA and clinicians at the workshop raised concern about high-dose prescribing, including levels above 500 ng/dL, which is in the male range. Long-term effects at those levels are unknown.[4]

What I Want the FDA to Hear

I am a board-certified OB-GYN with more than 20 years in practice, and my work now is entirely focused on hormone therapy for women in midlife. This is what I see, and what I want the agency to act on.

1. Don't limit testosterone to libido. Desire is where the trials were done, not where the benefit ends. Fund and require trials that measure energy, mood, mental clarity, muscle strength, and bone.
2. Study it the way women actually use it. Most women on testosterone are also on estrogen and progesterone. The hormones work together. Trials should record estrogen status at the start and study testosterone as part of a full regimen.
3. Approve physiologic, female-range dosing. A low-dose transdermal product, dosed for women and adjusted to symptoms, is what my patients need. Not pellets that cannot be removed. Not male doses.
4. Remove testosterone from Schedule III for women at physiologic doses. Its controlled-substance status makes prescribing across state lines by telehealth harder, and pharmacies may limit supply. The FDA's own expert panel recommended removing testosterone from controlled-substance status in December 2025.[6]
5. Protect access while approval is pending. Until an FDA-approved product exists, compounded testosterone from a quality pharmacy, prescribed and monitored by a physician, is how many women get safe, appropriate doses. The solution to poor compounding is standards, not a ban that leaves women with nothing.

I am submitting these points to the FDA docket before the October 19 deadline.

What This Means for You Right Now

An FDA-approved product for women is likely still years away. The trials the agency asked for take time. In the meantime, testosterone remains a legal, off-label option that a knowledgeable physician can prescribe.

Women who may be good candidates:

• Low desire that has not improved with estrogen and progesterone
• Surgical menopause, where testosterone drops sharply
• Persistent low energy or loss of strength after hormones, thyroid, iron, and sleep have been addressed

What a responsible approach looks like:

1. Rule out other causes first. Thyroid, iron, sleep, medications such as SSRIs, and relationship factors all affect desire and energy.
2. Use female-range doses, applied to the skin. I use transdermal testosterone because the dose can be adjusted up or down. Pellets cannot be removed if the dose is too high.
3. Let symptoms guide the dose. We start low and adjust based on how you feel.
4. Watch for androgen effects. Acne, unwanted facial hair, scalp hair thinning, and voice changes. Voice changes can be permanent, so report them early.

What to avoid: clinics that push high doses, promise results for everything, or prescribe without follow-up. The FDA workshop flagged exactly these practices.

How to Submit Your Own Comment by October 19

The FDA asked to hear from women directly, and every comment becomes part of the official record the agency has to consider. It takes about ten minutes.

1. Go to the docket on Regulations.gov, docket number FDA-2026-N-5479.
2. Click Comment.
3. Write in your own words. Useful details include whether you have used testosterone, how it affected you, whether you struggled to find a prescriber or pharmacy, and what you would want from an approved product.
4. Submit by 11:59 p.m. Eastern Time on October 19, 2026.

Comments are public. You can submit anonymously if you prefer.[6]

Your story counts. The FDA said at the workshop that women's voices are part of why this issue is back on its agenda.[5]

Frequently Asked Questions

Is testosterone FDA-approved for women? No. There is no FDA-approved testosterone product for women in the United States. It is approved for low sexual desire in postmenopausal women in Australia, New Zealand, the United Kingdom, and South Africa.

Is it legal for my doctor to prescribe testosterone? Yes. Physicians can prescribe testosterone off-label, using male products at much lower doses or compounded preparations.

What did the FDA decide at the September 2026 workshop? The workshop did not approve anything. The FDA signaled it wants to work with drug companies on products for women and named the data it needs, including cardiovascular, breast cancer, and long-term safety.

What is testosterone proven to help in women? The strongest evidence is for low sexual desire in postmenopausal women. Benefits for energy, mood, cognition, muscle, and bone are reported clinically but have not yet been confirmed in large controlled trials.

What are the side effects? At female-range doses, side effects are uncommon. They include acne, unwanted hair growth, scalp hair thinning, and, rarely, voice changes that can be permanent.

When is the FDA comment deadline? October 19, 2026, at 11:59 p.m. Eastern Time, on docket FDA-2026-N-5479.

The Bottom Line

Women have waited more than twenty years for the FDA to take testosterone seriously. It finally is. Until an approved product arrives, the right testosterone therapy is thoughtful, female-dosed, and monitored, and part of a full hormone plan rather than a quick fix.

Book your complimentary discovery call at doctoranat.com.

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Dr. Anat Sapan is a board-certified OB-GYN and menopause specialist with more than 20 years of experience, focused on personalized bioidentical hormone therapy for women in their 40s, 50s, 60s, and beyond. She sees patients by telemedicine in California, Florida, Illinois, and New York.