FDA Examines Rising Off-Label Use of Testosterone Prescriptions for Menopause

The FDA is watching a trend it cannot stop. More menopausal women are asking for testosterone, and doctors are giving it to them — even though there is no FDA-approved testosterone formulation for women in the United States. The agency held a public workshop Thursday where specialists admitted the practice is widespread but warned that the long-term safety questions remain unanswered.

The rise in off-label prescribing comes amid a broader surge in hormone replacement therapy, or HRT, among middle-aged women. HRT typically combines estrogen with or without progesterone to replace declining hormones during menopause. Its popularity has grown sharply since the FDA removed its “black box” warning label from HRT products earlier this year, followed by the removal of the warning on testosterone products.

But testosterone is not the same as estrogen. It is produced at about three times the rate of estrogen in premenopausal women, making it the most abundant sex hormone in women before menopause. As women age, their testosterone levels drop gradually, and low levels have been linked to loss of bone density, muscle mass, cognition, mood, sexual function and energy.

What the FDA’s Own Expert Said

Dr. Christina Chang, division director of the division of urology, obstetrics and gynecology in the FDA’s Center for Drug Evaluation and Research, made the admission at the workshop. There are no FDA-approved uses for testosterone therapy for menopausal women, she said. Because there is no approved formulation for women, clinicians who prescribe the hormone do so off-label and use smaller doses of testosterone products designed for men.

Chang noted that the agency is aware of increasing off-label use of testosterone among women experiencing menopause. Her statement carries weight because it comes from the person running the division responsible for approving new drugs.

Why Women Are Asking For It

The evidence supporting testosterone therapy in women is currently focused on hypoactive sexual desire disorder, a condition characterized by persistently low sexual desire that causes distress. That is the approved use, and it is narrow. Current guidelines do not consider testosterone therapy a treatment for energy or mood problems.

But women are seeking testosterone for those very symptoms, according to specialists at the FDA workshop. The broader range of concerns includes energy and mood, and based on current guidelines, testosterone therapy is not considered a treatment for those symptoms.

Measuring Testosterone In Women Is Hard

One of the biggest obstacles is that there is no blood-test threshold that can diagnose whether a woman has a testosterone deficiency. Concentrations are much lower than in men, so measuring them accurately is difficult.

There is also no agreed threshold for what counts as too low. Unlike estrogen, testosterone levels do not suddenly fall when women reach menopause. Instead, there is a gradual decline across the premenopausal years, according to Dr. Margaret Wierman, professor of medicine at the University of Colorado School of Medicine, who spoke to ABC News.

The Numbers Behind The Surge

HRT prescriptions among women ages 50 to 65 rose 72% from 2021 to 2025, according to data from Epic Research. That figure captures the shift in how menopause is treated, and testosterone is now part of that conversation.

The FDA’s moves on labeling have changed the landscape. Removing the black box warning on HRT products for menopause earlier this year was followed by the removal of the warning on testosterone products. Chang’s statement that women should not have to suffer through menopause reflects a view that hormonal support is normal, not exceptional.

“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,” Chang said.

The Questions That Remain Unanswered

The workshop made clear that the safety questions are not settled. Key questions about the long-term effects of testosterone therapy in menopausal women remain unanswered, and the FDA is looking to manufacturers to provide answers.

Here is what the agency still needs to know, in rough order of urgency:

1. Long-term safety data for women taking testosterone over many years.
2. Blood thresholds for diagnosing testosterone deficiency in women.
3. Whether testosterone improves energy and mood in menopausal women beyond sexual function.
4. How testosterone interacts with other menopausal treatments, including HRT.

What This Means For Patients

For women considering testosterone, the takeaway is simple: the science is not complete. Off-label prescribing means doctors are using testosterone products designed for men at smaller doses, and the FDA itself admits there is no approved use for women.

The agency is asking for data, not banning the practice. Chang’s statement that women should not have to suffer through menopause shows the FDA wants to help, but it wants evidence first.

The surge in HRT prescriptions suggests that menopausal women are increasingly willing to take hormones. Testosterone is simply the newest addition to that mix.

The Verdict On The FDA’s Position

The FDA is gathering evidence and reaching out to manufacturers. It is not shutting down off-label prescribing, but it is raising the alarm about unanswered questions.

The FDA’s position is acknowledge the practice, raise the safety flag, and push for the data. That is a sensible approach. It allows doctors to prescribe while the science catches up, but it also puts the spotlight on a field that has moved faster than the research.

The irony is that testosterone is natural in women. It is the most abundant sex hormone in premenopausal women, produced at about three times the rate of estrogen. Yet the medical establishment has treated it as a male-only concern for decades.

That contradiction is now coming to a head. Women want it, doctors are giving it, and the FDA is trying to make sure nobody gets hurt along the way.

The path forward is clear. Manufacturers need to produce the studies that the FDA wants. Those studies need to measure long-term safety, define thresholds, and test whether testosterone helps with energy and mood. Only then can the FDA move from acknowledging off-label use to approving it.

Until then, women who want testosterone should talk to their doctors about the unknowns. The FDA has spoken, and it has asked for answers.

Source material: “FDA examines use of testosterone prescriptions for menopause,” ABC News.

FDA · hormone therapy · menopause · testosterone · women's health