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A retrospective electronic health record study found higher rates of cardiovascular events among postmenopausal women who started testosterone than among matched women who did not. The authors stress that the finding shows an association, not proof of causation, and that further research is needed.
A retrospective study of postmenopausal women found that those who started testosterone therapy had higher rates of cardiovascular events than matched women who did not use it. The research, presented at the Menopause Society annual meeting, identifies a possible safety concern but does not establish that testosterone caused the difference.
Researchers used the TriNetX electronic health record network to compare women age 45 and older who initiated testosterone with women who were not exposed to the treatment. After matching the groups for measured characteristics, the analysis included 3,164 women in each group. Women with previous cardiovascular disease and certain other conditions were excluded. Average follow-up was 2.6 years.
At five years, a composite of coronary artery disease, cerebrovascular disease and heart failure was recorded in 3.8% of testosterone users and 0.5% of the comparison group. The researchers reported a hazard ratio of 8.08 (95% confidence interval 4.72-13.83). At 10 years, the recorded rates were 5.3% and 0.5%; in an unrestricted follow-up analysis, they were 6.2% and 1%. Those analyses also showed elevated hazard ratios, though the study’s follow-up and event counts limit how confidently the results can be interpreted.
The researchers also compared women receiving testosterone alongside menopausal hormone therapy with women taking menopausal hormone therapy alone. That analysis showed a higher cardiovascular risk in the testosterone group at the study’s measured intervals. Lead author Xuezhi (Daniel) Jiang of Drexel University College of Medicine and Tower Health’s Reading Hospital said the findings should be treated as a reason for more research, not as proof that appropriately prescribed testosterone causes cardiovascular disease.
A Safety Signal Without Causal Proof
The findings matter because cardiovascular disease is common, while long-term evidence about testosterone’s cardiovascular safety in women is limited. The study raises a question clinicians and patients may want to discuss when considering treatment, especially given the higher event rates reported in the analysis.
But the results do not show that testosterone itself produced the events. Retrospective studies can identify associations, yet differences between treatment groups may remain even after statistical matching. The researchers also reported few cardiovascular events overall, making the estimates less certain than the large hazard ratios alone might suggest. The study is a safety signal for further investigation, not a basis for concluding that all menopause-related testosterone use carries the same risk.
Why Testosterone Is Prescribed Off-Label
There are no FDA-approved testosterone products for women, although some clinicians prescribe low doses of products formulated for men off-label. Evidence that testosterone relieves menopausal symptoms is limited; some research suggests a benefit for women experiencing low sexual desire. The study does not determine whether treatment is effective for a particular symptom or patient.
Earlier clinical trials have generally been small or short and were not designed to measure major cardiovascular events over the long term. Jiang said the research team used a large, multicenter health record database to examine the question. The database, however, did not provide key treatment details, including testosterone dose, formulation, route, delivery method or reason for prescribing it.
“Our findings suggest that testosterone use is associated with a higher risk of cardiovascular events in postmenopausal women.”
— Xuezhi (Daniel) Jiang, lead study author
Dose and Cause Remain Unknown
The study cannot determine whether testosterone caused the higher event rates or whether unmeasured differences between the groups contributed. Researchers noted potential misclassification and residual confounding, as well as the relatively short mean follow-up and small number of events. TriNetX did not record the dose, formulation, route, delivery or indication for testosterone, so the analysis cannot show which treatment patterns, if any, were associated with the results.
The authors cautioned against generalizing the findings to all postmenopausal women, including those receiving guideline-concordant physiologic-dose transdermal testosterone. It is also unclear how the risk estimates would apply to individual cardiovascular outcomes, since the primary measure combined several conditions.
Prospective Studies Are Needed
Jiang said the findings should be validated in prospective studies, which can follow participants under a defined research plan and collect more detailed information about treatment. Future work should also examine individual outcomes, rather than relying only on the combined cardiovascular measure, and track dose and delivery method.
Until such evidence is available, this study does not settle the cardiovascular safety question or establish a treatment rule. People considering testosterone for menopause symptoms can discuss the potential benefits, uncertainties and their personal health history with a qualified clinician.
Key Questions
Did the study prove testosterone causes heart disease?
No. It found an association between starting testosterone and higher cardiovascular event rates in a retrospective analysis. The researchers said the design cannot establish that the treatment caused the difference.
What cardiovascular events did the study count?
The main outcome combined coronary artery disease, cerebrovascular disease and heart failure. The authors said further research should examine individual outcomes as well.
Are testosterone products approved for menopause treatment in women?
The source report says there are no FDA-approved testosterone products for women. Some clinicians prescribe low doses of products formulated for men off-label.
Does this finding apply to every woman using testosterone?
That is not known. The database lacked information on dose, formulation, route, delivery and treatment indication, and the authors cautioned against generalizing the results to all women receiving guideline-concordant physiologic-dose transdermal testosterone.
What research is needed next?
The authors called for prospective studies to validate the association, gather detailed treatment information and assess specific cardiovascular outcomes.
Source: rss
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