On September 17, 2026, the FDA held its first-ever public workshop dedicated to testosterone in menopausal women, after more than two decades without a single approved product for women while men have had more than a dozen. Here is the history, what just happened, and where Canada stands.
Testosterone is not just a male hormone. Women’s ovaries and adrenal glands produce it too, and levels decline gradually starting in a woman’s 20s, long before menopause.
A landmark 2005 study of more than 1,400 women in the Journal of Clinical Endocrinology & Metabolism found testosterone declines gradually over decades, falling by roughly 50 percent between age 20 and 60; a 2025 study of more than 1,100 women confirmed the same pattern. That decline does not pause before menopause. It is one long slide that is still underway when perimenopause and menopause arrive, and by then the cumulative loss is real.
That is different from estrogen, which falls roughly tenfold in the much shorter window around menopause itself. Testosterone’s drop is not a single menopause-triggered event; it is decades in the making, which is part of why women often feel the effects most acutely once menopause layers estrogen’s sharp loss on top of testosterone’s long, quieter one. Surgical removal of the ovaries is the exception: that causes a sharp, immediate drop in both hormones at once.
Despite that, the United States has never had an FDA-approved testosterone product made for women. Not one, ever. Meanwhile men have more than a dozen approved options: gels, patches, injections, pellets, an oral capsule, even a nasal spray.
On September 17, 2026, that finally started to shift. The FDA held its first public workshop dedicated entirely to testosterone in menopausal women. This post covers how the gap got this wide, what happened at the workshop, and what is (and is not) happening in Canada.
Thirteen Products for Men, Zero for Women
FDA-approved testosterone products for men include Androderm, AndroGel, Fortesta, Testim, Vogelxo, Depo-Testosterone, Testopel, Aveed, Natesto, Xyosted, Jatenzo, Tlando, and Kyzatrex, covering gels, patches, injections, pellets, an oral capsule, and a nasal spray.
For women, the count is zero. Women with low testosterone today have exactly one option: off-label use of a product approved and dosed for men, at a fraction of the dose, or a compounded version made by a specialty pharmacy.
Neither path involves a product that was ever tested, dosed, or approved specifically for a woman’s body.
Put a number on the gap: testosterone therapy for men has been FDA-approved since December 1953, when testosterone enanthate (brand name Delatestryl) first cleared the agency. That is 73 years of approved options for men, and zero for women.
Getting the dose right is its own separate problem. Men’s tubes and packets are not built to be split into the tiny fractions women need, so patients and clinicians are often left guessing: is this one-tenth of a tube, or one-twentieth? Cleveland Clinic’s Dr. Pelin Batur described using kitchen measuring spoons and small syringes to portion out doses at the FDA workshop, admitting that for years “the math wasn’t mathing.” Updated guidance is only now settling on smaller, more precise starting doses.
Believed to Help With More Than Libido, But Not Yet Proven
Hypoactive sexual desire disorder, a persistent, distressing drop in sexual desire, is the only indication backed by strong trial evidence, drawn from meta-analyses covering more than 8,000 women, according to the 2019 global consensus statement on testosterone therapy presented at the FDA workshop.
Many women and clinicians also use testosterone off-label hoping it helps with mood, brain fog, energy, muscle strength, or bone density. Those experiences are real to the people reporting them, but the same global consensus review found no consistent evidence from controlled trials that testosterone improves depressed mood, cognition, bone density, or muscle mass and strength in menopausal women.
That is a gap in the research, not necessarily proof the effects are not real. Dr. James Simon, a longtime testosterone researcher, put it directly at the workshop: most research in this area stalled for 22 years because there was no approved product and no company or agency funding the studies that could settle the question either way.
The 2004 Rejection That Set the Tone
The US came close once. In 2004, Procter & Gamble sought approval for Intrinsa, a testosterone patch for surgically menopausal women with hypoactive sexual desire disorder (HSDD), a persistent, distressing drop in sexual desire.
An FDA advisory panel voted unanimously against approval that December, citing a lack of long-term cardiac safety data, even though the trial data showed a real clinical benefit. Procter & Gamble withdrew its application rather than face a formal rejection.
Intrinsa went on to be approved in Europe. It was never approved in the United States, and it was eventually discontinued there too.
In 2011, an FDA advisory committee stated plainly that HSDD is a significant medical condition affecting women. That acknowledgment did not lead to an approved product. It took another 15 years for the FDA to even hold a formal workshop on the topic.
So Why Did This Take 73 Years?
It is a fair question, and it is not one answer. Part of it is structural. From 1977 to 1993, the FDA’s own policy excluded women “of childbearing potential” from most early-phase drug trials, an exclusion that shaped nearly two decades of drug development before it was reversed.
Part of it is funding. Research on conditions that affect mostly women has historically been underfunded relative to conditions that affect mostly men. Premenstrual syndromes affect roughly 90 percent of women at some point, yet receive about one-fifth the research funding of erectile dysfunction, a condition affecting about 19 percent of men, according to a widely cited comparison of research investment. In the 1980s and 1990s, urologists built entire clinics and professional societies around men’s erectile dysfunction, culminating in a 1992 NIH consensus conference that helped clear the path to Viagra’s approval in 1998. Nothing comparable was built for women’s sexual health in that same window.
Part of it is that the science turned out to be genuinely harder, not just neglected. Regulatory lawyers who cover the FDA closely noted after the September workshop that testosterone for women runs into a cluster of difficult, overlapping problems: “testosterone for menopause” is not itself an indication, so sexual dysfunction, musculoskeletal health, cognition, and mood would each need their own dedicated trial; sexual-function studies are notorious for a high placebo response, which can hide a real treatment effect; and standard blood tests are not sensitive enough at the low concentrations found in women, so any study needs the more expensive LC-MS/MS method just to measure its own results accurately.
That combination played out directly in the one large US trial that got furthest along. BioSante Pharmaceuticals took a testosterone gel called LibiGel through years of study, including a safety trial that enrolled women at real cardiovascular risk. Panelists at the September workshop noted the safety data looked reassuring. But the efficacy trial failed, undone largely by that high placebo response, and the product never reached the FDA for a decision. The company that came closest did not fail on safety. It failed on the specific, unresolved statistical problem the FDA has still not solved for anyone.
And part of it is a straightforward catch-22. No company wants to fund years of expensive trials for a product without confidence the FDA will approve it, and the FDA cannot approve a product that has never been properly studied. Dr. James Simon put it plainly at the workshop: this research mostly stalled for 22 years because there was no approved product and no company or agency funding the studies that could change that.
What finally broke the stalemate was not a company deciding it was worth the risk. It was women. More than 80 percent of the public comments the FDA received on its December 2025 men’s testosterone panel were about women’s testosterone instead, according to FDA officials and legal analysts who covered the workshop, and FDA has said directly that volume of response is what put this back on the agenda after 22 years of near-silence.
A Telling Contrast, Five Months Apart
What happened earlier in 2026 makes the timing hard to ignore. In April 2026, the FDA published a notice inviting the makers of already-approved men’s testosterone products to submit supplemental applications for a new indication: treating low libido in men with idiopathic hypogonadism, low testosterone without a clear structural cause. Companies had a specific date, April 30, to make contact.
Five months later, women got a single-day public workshop and a request for more research. Not a fast-tracked supplemental application process. Not a specific submission deadline. A call for manufacturers to go and run the studies that do not yet exist.
Both tracks are reasonable regulatory steps on their own terms. Side by side, they show how differently the same agency, in the same year, treats a gap in men’s options versus a gap that has existed for women since testosterone therapy began.
What Happened on September 17
The workshop was hosted by the FDA’s Office of Women’s Health and its Center for Drug Evaluation and Research, running a full day at the agency’s White Oak campus and online.
Speakers covered how testosterone behaves across a woman’s life and a real practical problem: the standard blood test used for testosterone, an immunoassay, is not reliable at the low concentrations typical in women. The more accurate method, liquid chromatography-tandem mass spectrometry, is not what most labs use day to day, which complicates both research and everyday prescribing.
FDA officials were direct about next steps: manufacturers need to run the trials, and data from a product already approved in another country could potentially support a US application, but would still have to meet the same evidentiary bar as any other drug. The agency was explicit that the standard does not get lowered because a product already exists somewhere else.
It is worth being precise about what this workshop was and was not. It was not an approval decision, and the FDA did not signal a specific timeline or path toward one. It was a fact-finding session to identify what evidence is still missing.
A public docket, FDA-2026-N-5479, opened alongside the workshop for written comments on the risks and benefits of testosterone use in menopausal women. It stays open until October 19, 2026, and it is open to anyone, not just clinicians or industry.
In Their Own Words
Kaveeta Vasisht, MD, the FDA’s Associate Commissioner for Women’s Health, opened the workshop by framing the stakes plainly: “FDA regulated products should reflect the unique biology and needs of women.”
Admiral Brian Christine, HHS Assistant Secretary for Health, pointed directly at the US-Australia gap in his keynote: “Something’s wrong with that.” He closed with a direct challenge to the agency: “Move boldly. Move with purpose… get this done.”
Rachel Rubin, MD, a Georgetown urologist and workshop speaker, told the room that when the FDA asked for public comment on men’s testosterone therapy in December 2025, “more than 82 percent of the comments were about female testosterone.” She argued the reason came down to one word: “Legitimacy.”
James Simon, MD, who has researched testosterone in women since a 2000 paper in the New England Journal of Medicine, put the timeline in personal terms: the last time he appeared before the FDA on this exact topic was at the Intrinsa patch hearing, “nearly 22 years ago.”
Susan Amanda Swain Lake, the patient speaker, described what untreated menopause did to her in blunt terms: her “healthy libido tanked to a negative three,” and she closed with a plea that no woman should have to go through what she did to get answers.
The Controlled-Substance Question Is a DEA Call, Not FDA’s
Several speakers, including Dr. Batur, called on the FDA to lift testosterone’s controlled-substance status, arguing that the paperwork and DEA licensing burden this creates is a real barrier to prescribing it for women.
Dr. Chang clarified during the panel discussion that this is not the FDA’s decision to make. Testosterone’s Schedule III status came from anti-doping legislation, not a standard FDA drug-scheduling process, and “the final decision rests with the DEA, the Drug Enforcement Administration, not with the FDA.”
It is a useful distinction for anyone advocating on this issue: the agency running the workshop and the agency that controls the scheduling are not the same one.
Other Countries Are Already Ahead
Australia is the country to point to here. Its regulator, the Therapeutic Goods Administration, approved AndroFeme 1, a 1 percent testosterone cream, in November 2020 for HSDD in postmenopausal women. It has been available on prescription there since 2021.
That made Australia the first regulator in the world to approve a treatment for sexual dysfunction in postmenopausal women, a five-year head start on the country most likely to follow.
Approval has not fully closed the gap even there. Eight testosterone products are subsidized under Australia’s national drug plan, and all eight are approved for men; AndroFeme is not one of the subsidized options, so Australian women pay out of pocket for the one product built for them.
The evidence behind AndroFeme is thinner than the headline of international approval suggests. The randomized, placebo-controlled trial supporting it involved 36 women, the same study cited across the Australian, New Zealand, and UK regulatory filings. That is not a reason to dismiss it, but it helps explain why the FDA is asking for more before following suit.
What Is in the US Pipeline
One concrete candidate is moving through early conversations with the FDA. AVA-291, made by Aviva Bio, is a next-generation testosterone molecule engineered to resist aromatization, the process by which testosterone converts into estrogen in the body.
In lab studies, it showed roughly 1,000 times less potential to stimulate breast cancer cell growth compared with standard testosterone, a meaningful distinction given that breast cancer risk is one of the main safety questions regulators have about testosterone therapy in women.
Aviva Bio received FDA feedback on its development plan in January 2026. That is still an early step, well short of a completed clinical trial program, let alone an approval.
A Dosing Comparison Worth Getting Right
A comparison has been circulating that is worth fact-checking directly: the claim that trans women get an FDA-approved testosterone dose of about 30mg a day, while menopausal women get nothing approved at even 1mg.
This needs two corrections. It almost certainly means trans men, not trans women; trans women do not take testosterone as part of their care, they take anti-androgens and estrogen. Trans men, people assigned female at birth on masculinizing hormone therapy, are the ones using testosterone, typically in the 25 to 100mg a day range.
Second, none of that is FDA-approved for that use either. Masculinizing hormone therapy is off-label use of the same men’s-hypogonadism-approved products that menopausal women already use off-label, just at a much higher dose. Menopausal women’s off-label doses, by contrast, typically run about 0.25mg to 5mg a day, with roughly 1mg a day being a realistic middle figure, according to real-world dosing details shared at the September workshop.
So the real disparity is not about who has FDA approval, since neither group does. It is about legitimacy and access: a 25 to 100mg dose for masculinizing therapy has become normalized, more consistently covered clinical practice, while a fraction of that dose for menopausal women still runs into pharmacist refusals and denied insurance claims, the exact problem Dr. Rubin described from her own practice.
What the Safety Data Still Does Not Answer
The FDA’s own safety reviewer, Linda Jaffe, MD, was candid about the gaps. The Nurses’ Health Study, a large prospective study, found a two-and-a-half-fold increase in breast cancer risk among women using estrogen plus testosterone together, with a 17 percent increase in risk for every additional year of use.
A separate UK claims-database study found no difference in heart disease risk between testosterone users and non-users in the short term, but the two groups’ risk began to diverge after about six and a half years, at which point testosterone users showed double the rate of ischemic heart disease.
Dr. Jaffe was clear that these findings come from imperfect study designs, healthy-user bias and confounding with concurrent estrogen use among them, not definitive answers. Her conclusion: long-term cardiovascular and breast cancer risk remain genuinely unresolved, which is exactly the kind of data an approved product, with mandated post-market monitoring, would help settle.
The Real Cost of Having No Approved Option
None of this is theoretical for the women already using testosterone. Prescriptions for women rose 146 percent between January 2023 and July 2026, largely for perimenopausal and menopausal symptoms, according to reporting published the same day as the FDA workshop.
Most US insurance plans do not cover it, since there is no approved product for women to cover. A compounded three-month supply can run about $100, compared with roughly $30 for ten months of a commercial product that is covered because it is approved, for men.
Pharmacy denials and delays are common in the US too. In one practice cited in that reporting, more than a third of patients using testosterone had run into a problem filling the prescription at a major chain pharmacy, sometimes losing hours trying to get a discount coupon honored. Amazon Pharmacy has reportedly stopped filling these tubes altogether, and Dr. Rachel Rubin, a urologist who testified at the FDA workshop, described a pharmacist telling her patient just two days before the workshop that testosterone “is only for men.”
We looked for equivalent Canadian reporting on pharmacies refusing to fill these prescriptions and did not find documented cases at the same scale as the US pattern. That does not mean it never happens to a Canadian woman, only that it has not been reported or studied the way the US pattern has been.
Insurance coverage may also work differently here. Canadian private drug plans typically cover any prescription with a valid Health Canada drug identification number, prescribed as medically necessary, often without requiring the use to match the drug’s approved indication. That is a different model from many US insurers, who frequently require prior authorization tied to an on-label diagnosis, which may be part of why some Canadian women report easier coverage for off-label testosterone gel. Coverage still varies by plan, and we could not find a study confirming how many Canadian plans cover it in practice, so this is a plausible explanation rather than a confirmed number.
Where Canada Stands
Health Canada has not approved a testosterone product for women either. On this specific question, Canada and the US are in the same position: zero approved options, off-label prescribing filling the gap.
Canadian menopause guidelines do support off-label transdermal testosterone as an option for postmenopausal women with low desire. Dosing guidance is largely extrapolated from Australia’s approved cream, and it is not fully clear whether the 1 percent testosterone gel available in Canada is even bioequivalent to it.
There is no Canadian equivalent to the FDA’s September workshop, no public docket, and no visible domestic process working toward a made-for-Canada approval. For now, a Canadian woman’s access to testosterone therapy depends entirely on a prescriber’s willingness to prescribe off-label, using evidence borrowed from another country’s approved product.
There is no comparable Canadian data to match the 146 percent US prescription jump for testosterone specifically. Canadian insurers have reported a real rise in hormone therapy claims overall in recent years, but that growth is overwhelmingly estrogen and progesterone, not testosterone, so citing it as a testosterone stat would be misleading. On testosterone specifically, the honest answer is that the data does not exist yet.
Women Deserve This Now, Not in a Decade
Women in the US and in Canada deserve better than this, and they deserve it now, not another decade from now. It took 22 years from the last time this question reached the FDA to the next real conversation about it. It has taken zero years, ever, for Health Canada to open one of its own.
Women have waited long enough for a product built for their bodies, priced and covered like the options men have had for 73 years, and dosed off a label instead of a kitchen measuring spoon. The researchers, the manufacturers, and the regulators on both sides of the border now have what they need to start moving. What is still missing is the urgency.
Why This Matters
A hormone gap that starts at the regulatory level ends up at the pharmacy counter. Every year without an approved product for women is another year of imprecise off-label dosing, inconsistent insurance coverage, and prescribers extrapolating from products that were never tested on the people now using them.
The September workshop is a real, first step, not a finished one. Whether it turns into an actual approved product depends on manufacturers doing the trials the FDA just asked for, and on regulators in Canada eventually opening a process of their own.
Testosterone for Women: Where Things Stand
| United States | Zero FDA-approved products for women, versus 13+ for men (men’s approval dates to 1953). First-ever FDA workshop on the topic held September 17, 2026, not an approval decision. Public docket FDA-2026-N-5479 open until October 19, 2026. No approved product yet; off-label and compounded use only. |
| Australia | First country in the world to approve a testosterone product for women: AndroFeme 1 cream, approved November 2020, available since 2021, based on a single 36-woman randomized trial. Not subsidized under the national drug plan, unlike all eight men’s testosterone products. |
| Canada | No Health Canada-approved product for women. Off-label prescribing supported by guidelines, with dosing extrapolated from Australia’s approved cream. No public regulatory process underway. |
| AVA-291 (Aviva Bio, in development) | Next-generation testosterone molecule designed to resist conversion to estrogen; about 1,000 times less breast-cancer-cell-stimulating potential in lab studies than standard testosterone. Received FDA development feedback in January 2026; still early-stage. |
I am not a doctor. Always talk to your own doctor before starting, stopping, or changing any medication, including any off-label or compounded hormone therapy.
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Aimee Debow is the Founder of Menovate and a certified Menopause Coach. She appeared as a witness before the House of Commons Standing Committee on the Status of Women in June 2026. Menovate helps Canadian organizations build menopause-supportive workplaces through corporate talks, e-learning, and HR advisory services. Learn more at menovate.ca.