U.S. health regulators are set to examine the scientific evidence surrounding testosterone therapy for menopausal women, as more women turn to the treatment for certain symptoms.

The review will focus on the potential benefits and risks of testosterone use, along with appropriate dosing, safety considerations and its broader role in women’s health. Doctors and patients are also expected to provide perspectives during the public meeting.

There is currently no U.S. Food and Drug Administration-approved testosterone product specifically designed for women. However, testosterone has been used off-label for years, particularly for women experiencing hypoactive sexual desire disorder (HSDD), a condition involving persistently low sexual desire.

The absence of a female-specific product can create practical challenges for healthcare providers. An approved treatment could potentially establish standardized dosing, labeling and safety-monitoring guidance for clinicians.

It could also affect access to treatment, including the possibility of improving insurance coverage for women who meet appropriate medical criteria.
The FDA said the meeting could help identify areas requiring additional research and potentially inform future drug development.

The discussion comes as interest in testosterone therapy grows among menopausal women seeking treatment options for symptoms associated with hormonal changes. However, questions remain about the appropriate use, dosage, long-term safety and effectiveness of testosterone in women.

The regulatory review is expected to bring together scientific evidence alongside experiences from healthcare professionals and patients, helping identify priorities for future research into testosterone therapy for menopausal health.