TL;DR
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A retrospective study presented at the Menopause Society meeting found higher rates of cardiovascular events among postmenopausal women who initiated testosterone therapy than among matched women who did not. The researchers say the findings show an association, not proof that testosterone caused the events; dose and treatment details were unavailable.
A retrospective study of postmenopausal women found that those who initiated testosterone therapy had higher rates of cardiovascular events than matched women who did not receive the treatment, researchers reported at the Menopause Society annual meeting. The findings do not establish that testosterone caused the events, and the study did not record patients’ doses or treatment formulations.
At five years, cardiovascular events were recorded in 3.8% of the testosterone group, compared with 0.5% of the unexposed group. The study’s composite outcome included coronary artery disease, cerebrovascular disease and heart failure. Researchers also reported an elevated hazard ratio for the outcome at five years (HR 8.08; 95% CI 4.72-13.83).
The analysis used the TriNetX electronic health record network to identify postmenopausal women aged 45 and older who started testosterone therapy. After propensity-score matching, the study compared 3,164 women in each group. Women with prior cardiovascular disease and certain other conditions were excluded. Mean follow-up was 2.6 years, despite analyses of outcomes over longer time windows.
The reported association remained in the 10-year analysis: events occurred in 5.3% of women exposed to testosterone and 0.5% of controls (HR 11.50; 95% CI 6.78-19.50). In the unrestricted follow-up analysis, the figures were 6.2% and 1%, respectively (HR 5.92; 95% CI 4.09-8.56). These percentages describe the study groups and do not show that testosterone itself caused the difference.
Why Heart Safety Needs Closer Study
The findings add to uncertainty about the long-term cardiovascular safety of testosterone prescribed during menopause. They matter to patients and clinicians weighing treatment because cardiovascular disease is a common health concern, while evidence about testosterone’s benefits and risks in women remains limited.
However, the results are not a reason to conclude that all testosterone use carries the same risk. The study could not distinguish doses, formulations, routes of administration or reasons for prescribing. Its authors cautioned against generalizing the findings to women receiving guideline-concordant physiologic-dose transdermal testosterone. The study raises a question for further research; it does not settle treatment decisions.
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Limited Evidence on Menopause Treatment
There are no FDA-approved testosterone products for women, although some clinicians prescribe low doses of products made for men off-label. Evidence that testosterone eases menopausal symptoms is insufficient overall; some research suggests it may help women with low libido.
Prior trials have often involved small groups or short follow-up and were not designed to assess major cardiovascular events, according to lead researcher Xuezhi (Daniel) Jiang, MD, PhD, of Drexel University College of Medicine and Reading Hospital. He said the team used a large, multicenter electronic health record database to examine the question. The resulting observational analysis can identify patterns in recorded care, but it cannot by itself determine whether treatment caused an outcome.
“Our findings suggest that testosterone use is associated with a higher risk of cardiovascular events in postmenopausal women.”
— Xuezhi (Daniel) Jiang, MD, PhD, lead researcher, speaking to MedPage Today
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Dose and Cause Remain Unknown
The study was retrospective, so residual confounding—differences between patients that were not measured or accounted for—could help explain the findings. The researchers also cited possible misclassification, relatively short average follow-up and few cardiovascular events overall. TriNetX records did not provide testosterone dose, formulation, route, delivery method or clinical indication.
The reported hazard ratios compare event rates between study groups; they do not establish that testosterone was the reason for the difference. It is also unclear whether the association applies to specific treatment regimens or to women who meet guidelines for physiologic-dose transdermal use. The findings have not, on the information reported, been validated by a prospective study.
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Prospective Research Is Needed
Jiang said the results should be validated in prospective studies, which could follow patients under a planned research protocol and collect more detailed treatment information. Future work should also examine individual cardiovascular outcomes rather than relying only on a composite measure.
Until stronger evidence is available, this study provides a signal for further investigation rather than a definitive answer about testosterone’s cardiovascular effects. It does not specify how individual patients should change treatment; decisions about menopause care should be discussed with a qualified clinician.
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Key Questions
What did the study find?
In a matched retrospective comparison, cardiovascular events were recorded in 3.8% of women who initiated testosterone and 0.5% of unexposed women over the five-year analysis. The study found an association, not proof of cause and effect.
Does this prove testosterone causes heart disease?
No. The observational design cannot establish that testosterone caused the events. Unmeasured differences between patients and other study limitations may have influenced the results.
Did the researchers know what doses or products women used?
No. The TriNetX data did not include the testosterone dose, formulation, route, delivery method or reason for treatment, limiting conclusions about particular regimens.
Are testosterone products approved for menopause treatment in the United States?
The report says there are no FDA-approved testosterone products for women. Some clinicians prescribe low doses of products made for men off-label.
What research is needed next?
The study’s authors called for prospective studies to validate the association and research that examines individual cardiovascular outcomes and records treatment details.
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