TL;DR
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A retrospective study of postmenopausal women found higher rates of cardiovascular events among those starting testosterone than among matched women not receiving it. The researchers caution that the findings do not prove testosterone caused the events and may not apply to appropriately prescribed, physiologic-dose transdermal treatment.
A retrospective study presented at the Menopause Society annual meeting found that postmenopausal women who started testosterone therapy had more recorded cardiovascular events than matched women who did not receive the treatment. The researchers stressed that the finding is an association, not proof of causation, and that the study does not establish the risk for women using appropriately prescribed, physiologic-dose transdermal testosterone.
The study used records from the TriNetX research network to compare women aged 45 and older who initiated testosterone therapy with a control group not exposed to it. After propensity score matching, each group contained 3,164 women. Women with prior cardiovascular disease and certain other conditions were excluded. The average follow-up was 2.6 years.
Within five years, the study recorded cardiovascular events in 3.8% of the testosterone group, compared with 0.5% of the control group. The composite outcome included coronary artery disease, cerebrovascular disease and heart failure. The reported hazard ratio at five years was 8.08, with a 95% confidence interval of 4.72 to 13.83. The researchers also reported higher event rates in analyses extending to 10 years and across unrestricted follow-up, though the average follow-up for participants remained 2.6 years.
A sensitivity analysis comparing women receiving testosterone alongside menopausal hormone therapy with women receiving hormone therapy alone also found an association with higher cardiovascular risk. Study author Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Reading Hospital, said the results should prompt further study, not be taken as evidence that appropriately prescribed testosterone causes heart disease.
Heart Safety Evidence Remains Limited
The findings matter because some clinicians prescribe testosterone off-label to women experiencing menopause, while no testosterone product is FDA-approved for women. Evidence that the therapy eases menopausal symptoms is limited; some research suggests a benefit for women with low sexual desire. At the same time, long-term cardiovascular safety data for women are scarce.
The study offers a signal for clinicians and patients to discuss, but it does not provide a reliable estimate of an individual woman’s risk. The authors say the database lacked details about treatment dose, formulation, delivery route and indication. Without those details, the results cannot show whether the association applies to a particular treatment approach or to women receiving doses intended to keep testosterone within a physiologic range.
External expert Stephen Burgess, a biostatistics professor at the University of Cambridge, said the size of the observed difference was concerning, particularly because cardiovascular disease is common. He also cautioned that the study cannot prove testosterone caused the difference. Its results are a reason for further investigation rather than a basis for a definitive conclusion about treatment safety.
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Why Researchers Examined Testosterone
Clinical trials of testosterone therapy in women have often been small or short and were generally not designed to measure major cardiovascular events. Jiang said his team turned to a large, multicenter electronic health record database to examine the question. Observational records can identify patterns across many patients, but they are more vulnerable than randomized trials to differences between groups that researchers cannot fully measure or adjust for.
In this retrospective cohort study, the primary analysis covered cardiovascular events within five years of starting testosterone. The team also examined outcomes at 10 years and over unrestricted follow-up. At 10 years, the reported event rates were 5.3% among women exposed to testosterone and 0.5% among controls; in the unrestricted analysis, they were 6.2% and 1%, respectively. These time-based analyses showed a similar pattern, but they do not remove the study’s limitations or establish a cause.
“Our findings suggest that testosterone use is associated with a higher risk of cardiovascular events in postmenopausal women.”
— Xuezhi (Daniel) Jiang, MD, PhD, study author
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Treatment Details and Causation Unknown
The study cannot determine whether testosterone itself caused the higher event rates. Although the researchers matched participants and excluded people with prior cardiovascular disease and other complicating conditions, residual confounding may remain. Retrospective records may also contain misclassification, and the study reported relatively few cardiovascular events overall.
The database did not record the testosterone dose, formulation, route, delivery method or reason for prescribing it. That prevents researchers from separating outcomes by treatment type or determining whether the findings apply to guideline-concordant physiologic-dose transdermal therapy. The mean follow-up was 2.6 years, and the reported longer-term analyses do not substitute for prospective follow-up. It also remains unclear how the association varies across the individual outcomes grouped together as cardiovascular disease.
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Prospective Studies Needed
Jiang said the findings need validation in prospective studies, which could track treatment and outcomes more consistently over time. Future research should record dose and delivery method and distinguish coronary disease, cerebrovascular events and heart failure rather than relying only on a composite outcome.
Until those data are available, the study does not establish that testosterone therapy causes cardiovascular disease or define the safety of a specific regimen. The researchers’ stated next step is further investigation; the source report did not identify a scheduled follow-up study or a change to clinical guidance.
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Key Questions
Did the study prove that testosterone causes heart disease?
No. It was a retrospective observational study and found an association. The authors and an outside expert said it cannot establish that testosterone caused the cardiovascular events.
How many women were included?
After matching, the study included 3,164 women in each group: one group that initiated testosterone and one not exposed to it.
What cardiovascular outcomes did researchers count?
The main composite outcome included coronary artery disease, cerebrovascular disease and heart failure.
Does the result apply to every form of testosterone treatment?
That is not clear. The database did not include dose, formulation or route of delivery, and Jiang cautioned against generalizing the result to all menopausal women receiving physiologic-dose transdermal testosterone.
What research is needed next?
The study’s author called for validation in prospective studies and for research that examines individual cardiovascular outcomes and records how testosterone is prescribed and delivered.
Source: rss
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