Testosterone therapy for women lacks FDA-approved options

Key Points:

• The FDA held a public workshop to address the evidence, safety, and research gaps regarding testosterone therapy for menopausal women, as no testosterone product is currently FDA-approved for women in the U.S.
• Interest in testosterone therapy has increased due to menopause symptoms like low sexual desire and fatigue, but physicians must rely on off-label prescribing and compounded formulations, leading to dosing challenges and insurance denials.
• Current evidence-based guidelines support testosterone therapy only for hypoactive sexual desire disorder (HSDD), while clinical support for benefits in energy, mood, bone health, or sleep remains limited.
• Doctors often use male testosterone gels in micro-doses or compounded creams for women, but these approaches are inconsistent, costly, and require patients to self-administer precise doses without standardized guidelines.
• Advocates and clinicians are pushing for regulatory changes to improve access and treatment options for women, emphasizing that sexual health is an integral part of overall health.