Off-label testosterone prescriptions for menopause are increasing in the U.S., despite a lack of FDA approval and limited evidence supporting its effectiveness for most symptoms.

Prescriptions for off-label testosterone therapy among menopausal women in the U.S. rose by 58.7% in 2025 compared to 2024. Despite this growth, the FDA has not approved testosterone for treating menopause, perimenopause, or postmenopause, and experts warn that scientific evidence supporting its use for general menopausal symptoms remains limited.

Hormonal Misconceptions and Evidence

While many believe menopause is caused by a sharp decline in testosterone, experts note that testosterone levels in females actually decline gradually between ages 20 and 60. Menopause, typically occurring around age 51 or 52, is primarily driven by fluctuations and sharp declines in estrogen and progesterone. Clinical trials have not demonstrated that testosterone effectively alleviates common menopausal complaints such as brain fog, fatigue, or low mood. Placebo-controlled trials frequently show that about 30% to 40% of participants report symptom improvement while taking a placebo, complicating the evaluation of testosterone's efficacy. The FDA held a public workshop on September 17 to evaluate existing evidence, ultimately concluding that more research is required to assess the hormone's role in menopause treatment.

Sexual Health and Dosing Risks

Some evidence suggests testosterone may help treat hypoactive sexual desire disorder (HSDD) in postmenopausal women, with one review of 36 trials showing an average increase of 0.85 satisfying sexual events per month. However, testosterone is not FDA-approved for this use. Because most available testosterone treatments are formulated for men, doctors in the U.S. often adapt these higher-dose preparations for female patients, which can lead to unpredictable results. Excessive dosing carries risks of masculinizing effects, including voice deepening, hair thinning, baldness, and clitoral enlargement. Furthermore, the long-term impacts of testosterone on cardiovascular health and breast cancer risk remain poorly understood. Only four countries—Australia, South Africa, New Zealand, and the United Kingdom—have authorized specific, lower-dose testosterone creams formulated for women.