In 2025, off-label testosterone prescriptions for women aged 45 to 64 jumped by 58.7 percent. Despite this surge, the U.S. Food and Drug Administration (FDA) has not approved the hormone for treating menopausal symptoms.
The 58.7 percent jump in off-label prescriptions
Recent data indicates that more than 90,000 off-label prescriptions for testosterone were issued to women in 2025, according to the report. This spike is particularly concentrated among women diagnosed with menopause or those in the 45-to-64 age bracket. because the FDA has not authorized testosterone for the treatment of perimenopause or post-menopause,these prescriptions fall into a regulatory gray area where clinicians prescribe a hormone traditionally linked to male physiology.
This trend reflects a growing disconnect between clinical guidelines and prescribing habits. While medical practitioners are increasingly responding to patient demand, the report notes that this rise is not supported by a confirmed decline in female testosterone levels during the menopausal transition.
Why the FDA has not approved testosterone for menopause
The lack of FDA approval stems from a fundamental biological reality: testosterone is not the primary driver of menopausal symptoms.. Research into organ-based hormonal changes shows that estrogen and progesterone are the hormones that fluctuate most violently duirng perimenopause and crash at the onset of menopause. In contrast, testosterone levels in women between the ages of 20 and 60 remain relatively stable, only showing a slight increase after age 60.
This biological context suggests that the "cognitive fog" and hot flashes associated with menopause are likely rooted in estrogen deficiency rather than a lack of testosterone. By prescribing testosterone to treat these symptoms, clinicians may be targeting the wrong hormonal pathway, a point emphasized by endocrinology experts cited in the source material.
The 0.85-event margin in sexual health trials
While social media forums are filled with anecdotal accounts of a "sexual awakening," the hard data is far less dramatic. In a large-scale trial involving 8,480 women, those using a testosterone patch reported only 0.85 more satisfying sexual events per month than those receiving a placebo. While this result is statistically significant, it is not considered a dramatic clinical improvement.
Furthermore, the drug remains unapproved for hypoactive sexual desire disorder (HSDD) in women. The report highlights a significant placebo effect in these studies, noting that as many as one in three participants reported symptom improvement even when they were given an inactive ingredient.. This suggests that the perceived benefits of testosterone may be driven more by expectation than by pharmacology.
The 2028 deadline for the testosterone cream trial
To resolve the conflict between investor enthusiasm and scarce evidence, a new large-scale trial is currently underway.. This study is enrolling several hundred menopausal women to test a testosterone cream designed for absorption through the thighs and lower abdomen, a method intended to reduce the risk of visible hair growth.
The trial aims to provide definitive answers on whether testosterone actually improves sleep quality, memory, anxiety, migraines, or overall body mass. However, as the report states, results are not anticipated until 2028. Until then, critical questions remain: does the cream offer a safer delivery mechanism than patches, and can it provide any benefit beyond the modest gains seen in HSDD? For now, the evidence for using testosterone to treat general menopausal symptoms remains lukewarm at best.
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