FDA Examines Testosterone Use for Menopause Amid Safety Concerns
Specialists caution about the long-term safety of testosterone therapy for menopausal women, citing a lack of FDA-approved formulations and limited evidence for broader symptom relief.
The Food and Drug Administration (FDA) is examining the use of testosterone prescriptions for menopausal women, a practice that has been increasing despite significant unanswered questions regarding its long-term safety. Specialists convened at an FDA public workshop Thursday to discuss the growing trend.
While testosterone is the most abundant sex hormone in premenopausal women, its levels gradually decline with age. Low testosterone has been linked to decreased bone density, muscle mass, cognition, mood, sexual function, and energy. However, there is no FDA-approved testosterone formulation for women in the United States. Consequently, clinicians often prescribe testosterone off-label, using smaller doses of products designed for men.
"There are no FDA-approved uses for testosterone therapy for menopausal women," said Dr. Christina Chang, division director of urology, obstetrics, and gynecology at the FDA's Center for Drug Evaluation and Research. She acknowledged the agency's awareness of the rising off-label use of testosterone among women experiencing menopause.
The primary evidence supporting testosterone therapy in women currently focuses on hypoactive sexual desire disorder, a condition characterized by persistently low sexual desire that causes distress. Yet, specialists at the workshop noted that women are seeking testosterone for a wider array of concerns, including energy and mood. Current guidelines do not endorse testosterone therapy as a treatment for these broader symptoms.
Measuring testosterone levels in women also presents challenges due to significantly lower concentrations compared to men, making it difficult to establish a blood-test threshold for diagnosing deficiency. Unlike estrogen, testosterone levels do not experience a sudden drop at menopause; instead, they decline gradually. "There is a gradual decline in testosterone levels across the premenopausal levels," stated Dr. Margaret Wierman, professor of medicine at the University of Colorado School of Medicine.
The heightened interest in testosterone coincides with a broader increase in hormone replacement therapy (HRT) for menopausal women. HRT, which typically involves estrogen with or without progesterone, saw a 72% rise in prescriptions among women aged 50 to 65 between 2021 and 2025, according to data from Epic Research. This surge follows the FDA's earlier removal of its "black box" warning label from HRT products for menopause.
"Menopause is inevitable, women should not have to suffer through it," Chang added. "To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data."