At a public workshop in Washington, the FDA convened researchers and clinicians to confront a quiet paradox: testosterone therapy is already woven into the lives of many menopausal women, yet the science meant to justify and guide that practice remains largely unwritten. No FDA-approved formulation exists for this use, no diagnostic threshold defines deficiency in women, and the long-term safety record is, by the agency's own admission, a blank page. The question being asked is not whether women deserve relief from the burdens of menopause, but whether medicine has earned the right to offer th
FDA Scrutinizes Off-Label Testosterone Use for Menopause as Safety Questions Linger
We need high-quality data before this becomes standard practice
Mark
So the FDA is saying testosterone for menopause is unsafe?
Mimi
Not exactly. They're saying we don't have enough long-term safety data to know. There's a difference. Women are already getting prescribed it off-label, but nobody has done the studies to show what happens over years.
Luke
Off-label means doctors are using a product approved for something else—in this case, men's testosterone—and giving it to women at lower doses. That's legal, but it means there's no FDA oversight of how it's being used in this population.
Mark
Why is measuring testosterone in women so hard?
Mimi
The concentrations are much lower than in men. So the blood tests we use aren't sensitive enough, and there's no agreed-upon threshold for what counts as "deficient" in women.
Luke
Which means a doctor can't actually diagnose a deficiency. They're prescribing based on symptoms—fatigue, mood, low libido—not on a measurable hormone level.
Mark
And women want it for all those reasons, not just sexual desire?
Mimi
Yes. The only use with solid evidence is hypoactive sexual desire disorder. But women are seeking it for energy, mood, bone health, muscle. Those aren't in the guidelines.
Luke
Though to be fair, testosterone does decline with age in women, and low levels have been linked to those things. The question is whether giving it back actually helps, and whether it's safe long-term.
Mark
What's the FDA actually asking for?
Mimi
High-quality data from manufacturers. Studies that show what happens when you give women testosterone over time.
Luke
And until they get that, the practice is in a gray zone. Legal, increasingly common, but not really studied in women.
Der Puls
- Testosterone is being prescribed to menopausal women at growing rates for energy, mood, and sexual function — yet every prescription is an off-label adaptation of a drug designed for men.
- The FDA's own specialists admitted at Thursday's workshop that long-term safety data for this use simply does not exist, leaving both patients and physicians navigating without a map.
- A fundamental biological obstacle compounds the uncertainty: women's testosterone concentrations are so low that no validated blood test can confirm a deficiency, making diagnosis more intuition than science.
- The surge in testosterone use is riding a broader wave — HRT prescriptions among women 50 to 65 have climbed 72% since 2021, accelerated by the FDA's removal of its longstanding black-box warning on hormone therapies.
- The FDA is not moving to restrict access but is pressing manufacturers for high-quality evidence, framing the moment as an urgent call for data before off-label practice quietly becomes the standard of care.
At a public workshop in Washington, the FDA convened researchers and clinicians to confront a quiet paradox: testosterone therapy is already woven into the lives of many menopausal women, yet the science meant to justify and guide that practice remains largely unwritten. No FDA-approved formulation exists for this use, no diagnostic threshold defines deficiency in women, and the long-term safety record is, by the agency's own admission, a blank page. The question being asked is not whether women deserve relief from the burdens of menopause, but whether medicine has earned the right to offer this particular answer.
At an FDA public workshop on Thursday, a disquieting question hung over the proceedings: as testosterone therapy becomes an increasingly common tool for managing menopause, does the medical community actually understand its long-term consequences? Regulators and researchers in the room largely agreed that the answer is no.
No FDA-approved testosterone formulation exists for menopausal women in the United States. Physicians who prescribe it — and more are doing so — adapt products made for men, using smaller doses off-label. Dr. Christina Chang, who leads the FDA's division covering urology, obstetrics, and gynecology, acknowledged the agency's awareness of this growing practice and the regulatory vacuum surrounding it.
The underlying biology is both compelling and complicated. Testosterone is actually the most abundant sex hormone in women before menopause, produced at roughly three times the rate of estrogen — though women carry about fifteen times less total testosterone than men. As women age, levels decline gradually, a slow erosion linked to losses in bone density, muscle mass, cognition, mood, and sexual function. Women are seeking testosterone therapy for all of these reasons, yet clinical guidelines only formally recognize one: hypoactive sexual desire disorder.
Diagnosis presents its own obstacle. Because women's testosterone concentrations are so much lower than men's, no established blood-test threshold exists to confirm a deficiency. As Dr. Margaret Wierman of the University of Colorado explained, the gradual, lifelong decline makes it nearly impossible to define what is abnormally low for any given patient.
This is unfolding against a broader shift in menopause care. HRT prescriptions among women ages 50 to 65 rose 72 percent between 2021 and 2025, a surge that followed the FDA's removal of its long-standing black-box warning from hormone therapy products — a signal of the agency's evolving risk-benefit calculus. Testosterone products lost their warning label as well.
Still, the regulatory path forward is unsettled. Chang was careful to frame the FDA's position not as a barrier but as a plea for rigor. "Menopause is inevitable, women should not have to suffer through it," she said, calling on manufacturers to supply the high-quality data the agency needs. The implicit message was pointed: a practice already reshaping women's healthcare deserves the science to match.
At an FDA public workshop on Thursday, medical specialists raised an uncomfortable question: as more menopausal women seek testosterone therapy, does anyone actually know if it's safe? The answer, according to regulators and researchers in the room, is that the long-term safety picture remains largely blank.
Testosterone therapy for women experiencing menopause is becoming more common, yet there is no FDA-approved testosterone formulation designed for this use in the United States. When doctors prescribe it anyway—which they increasingly do—they are adapting products originally developed for men, using smaller doses off-label. Dr. Christina Chang, who directs the FDA's division overseeing urology, obstetrics, and gynecology, acknowledged at the workshop that the agency is aware of this growing off-label use and the lack of regulatory clarity surrounding it.
The biology itself is straightforward enough. Adult men carry roughly fifteen times more total testosterone than women, yet testosterone is actually the most abundant sex hormone in women before menopause, produced at about three times the rate of estrogen. As women age, testosterone levels decline gradually—not in the sudden drop that characterizes estrogen loss at menopause, but as a slow erosion over years. That decline has been linked to losses in bone density and muscle mass, along with changes in cognition, mood, sexual function, and energy levels. The problem is that women are now seeking testosterone therapy for all of these reasons, even though current medical guidelines only recognize one: hypoactive sexual desire disorder, a condition of persistently low sexual desire that causes distress.
Measuring whether a woman actually has a testosterone deficiency presents a fundamental scientific obstacle. Because women's testosterone concentrations are so much lower than men's, there is no established blood-test threshold that can diagnose a deficiency. This means a doctor cannot simply order a test and get a clear answer about whether a patient needs treatment. Dr. Margaret Wierman, a professor of medicine at the University of Colorado School of Medicine, explained to ABC News that testosterone levels in women decline gradually across the lifespan, making it difficult to pinpoint what constitutes abnormally low levels.
The surge in testosterone prescriptions is happening within a broader shift in how menopause is being treated. Hormone replacement therapy—typically estrogen with or without progesterone—has seen prescriptions rise 72 percent among women ages 50 to 65 between 2021 and 2025, according to data from Epic Research. That increase followed the FDA's removal of its "black box" warning label from HRT products earlier this year, a decision that signaled the agency's reassessment of the risks and benefits of hormone therapy for menopausal women. The same warning was also removed from testosterone products.
Yet the regulatory pathway for testosterone in women remains unsettled. Currently, the evidence supporting its use is largely confined to sexual desire disorder. Specialists at the FDA workshop acknowledged that women are seeking it for a much wider range of concerns—energy, mood, overall quality of life—but these uses fall outside established clinical guidelines. Chang framed the challenge not as a reason to restrict access but as a call for better information. "Menopause is inevitable, women should not have to suffer through it," she said. "To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data." The FDA is essentially asking: before this practice becomes standard, can we please understand what we're doing?
Bemerkenswerte Zitate
Menopause is inevitable, women should not have to suffer through it. To best serve the American women we need high-quality data.— Dr. Christina Chang, FDA division director
Testosterone levels decline gradually across the lifespan in women, not in the sudden drop seen with estrogen at menopause.— Dr. Margaret Wierman, University of Colorado School of Medicine
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