Testosterone Therapy in Menopausal Women Tied to Higher Heart Disease Rates in Observational Study

Women who started testosterone therapy after menopause developed cardiovascular disease at a much higher rate than matched women who didn't, according to a study presented Oct. 20 at The Menopause Society's annual meeting in San Diego.

The finding is an association. The authors say so plainly, and the work has not been through peer review.

What the study found

Lead researcher Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Tower Health's Reading Hospital, used the TriNetX research network, a large database of electronic health records. He and a colleague looked at postmenopausal women 45 and older who began testosterone therapy and compared them with women who did not.

Women with prior cardiovascular disease and other complicating conditions were excluded. After propensity score matching, each group had 3,164 women. Mean follow-up was 2.6 years.

The primary outcome was a composite of incident coronary artery disease, cerebrovascular disease and heart failure. Over five years, the hazard ratio for testosterone users was 8.08 (95% CI 4.72 to 13.83). It was 11.50 at 10 years and 5.92 with no time limit on follow-up.

In plain numbers, 3.8% of women on testosterone developed cardiovascular disease, compared with 0.5% of those who did not. The association also held when women taking testosterone plus menopausal hormone therapy were compared with women on hormone therapy alone, according to the researchers.

What the authors and outside researchers say

"Our findings demonstrate an association between testosterone therapy and cardiovascular events, but they do not establish that testosterone directly causes these events," Jiang said.

He also noted that "absolute event rates were low," but said the consistency of the association across analyses "warrants further prospective investigation."

Stephen Burgess, PhD, a biostatistics professor at the University of Cambridge, called the roughly eight-fold difference concerning, given how common heart disease is. "While this study cannot prove that testosterone treatment is the cause of this difference in risk, it does raise concerns, particularly as the authors have accounted for several other potential causes," he said in comments posted to the Science Media Centre.

Dr. Stephanie Faubion, medical director of The Menopause Society, said cardiovascular disease remains the No. 1 killer of women and that long-term safety data on testosterone in women are lacking. "The findings are a reminder for healthcare professionals to carefully balance individualized risks and benefits when prescribing testosterone," she said.

Jiang offered possible mechanisms: effects on cholesterol metabolism, blood pressure and vascular function. The study was not designed to test any of them. Those effects may also depend on dose, delivery method and blood testosterone levels.

A growing off-label market

No testosterone product is FDA-approved for women in any form. Doctors prescribe low doses of male formulations off-label, most often for low sexual desire.

A 2026 U.S. study recorded more than 90,000 off-label testosterone prescriptions to women in 2025, mainly to women 45 to 64 with menopause diagnoses. That was a 58.7% jump from 2024.

The FDA declined in 2004 to approve a 300-microgram testosterone patch for women with low desire, citing uncertain benefits and too little long-term safety data. Over two decades later, no approved option exists. Men can choose from more than 30 products, according to the Parsemus Foundation, a nonprofit that backs research on testosterone for women.

The access argument

Not everyone reads that history as caution. Four OB-GYNs at Florida International University argued in an April 2026 narrative review in Cureus that the FDA should fund long-term trials and move toward approving a product for women. Their position: "Women deserve access to regulated, effective treatments grounded in scientific evidence."

The strongest evidence for benefit is in hypoactive sexual desire disorder. A 2019 meta-analysis pooled 36 randomized trials with 8,480 women, and the Parsemus Foundation points to it as the best-supported use. Jiang's own caution cuts the same way: most existing trials of testosterone in menopause were small or short and were not built to detect major cardiovascular events. In his words, the absence of a safety signal in selected trial populations is not the same as established long-term safety across broader populations.

Some menopause specialists told Everyday Health that more work is needed before they would tell women to avoid testosterone altogether.

Does it even work for menopause symptoms?

Susan Davis, a professor of endocrinology at Monash University in Australia who has run several of the trials herself, says the evidence outside of sexual desire is thin. Placebo-controlled trials have not shown that testosterone improves brain fog, well-being, mood, bone density or muscle function in menopausal women, she said.

Davis also rejects the idea that menopause brings an "androgen deficiency." Testosterone in women drifts down slowly between about ages 20 and 60, she said, and menopause itself is not tied to a sharp drop. "Telling women that fatigue, low mood, brain fog are symptoms of androgen deficiency is completely untrue," she said.

Limits and next steps

This is a retrospective database analysis. Women who get testosterone prescriptions may differ from those who don't in ways that matching can't fully capture. The findings were presented as a poster and are preliminary until published in a peer-reviewed journal.

The FDA held a public workshop on Sept. 17 to weigh the evidence for testosterone in menopause and concluded that more evidence is needed. The Menopause Society meeting runs through Friday, Oct. 23. Jiang and his colleagues are calling for prospective studies, and no such trial has been announced.