A large retrospective study found that postmenopausal women using testosterone therapy faced dramatically higher rates of cardiovascular events compared to untreated peers. The findings come as testosterone prescriptions for women have nearly tripled in recent years, despite no FDA-approved female-specific product existing. Experts say the results are hypothesis-generating and call for prospective studies before drawing firm conclusions.
A large retrospective cohort study presented at the Menopause Society annual meeting found that postmenopausal women using testosterone therapy had significantly higher rates of cardiovascular events compared to matched controls — an 8-fold elevated hazard at 5 years. The findings, drawn from over 3,000 women per group in the TriNetX database, persisted across 5-year, 10-year, and unrestricted follow-up windows, raising important questions about a therapy that has seen prescriptions nearly triple over the past five years.
The backdrop matters: there is still no FDA-approved testosterone product for women in the US, and most prescriptions rely on off-label male formulations. Experts at a recent FDA public workshop emphasized that evidence only firmly supports testosterone for hypoactive sexual desire disorder (HSDD) in postmenopausal women — not for mood, cognition, muscle mass, or general well-being. Women are also running into pharmacy denials and insurance barriers due to the lack of a female-specific approved product.
By the Numbers:
Why it matters: With testosterone use among menopausal women surging — fueled partly by social media — this study adds an important caution signal. While the observational design limits causal conclusions, the magnitude of the association underscores the need for prospective trials and a female-specific FDA-approved product with proper safety monitoring.
