Dr. Kelly Casperson on Testosterone for Women at FDA Menopause Hearing

The Need for Female-Dose Testosterone

• 💡 Testosterone, a safe and inexpensive hormone developed in 1935, is still unavailable in FDA-approved doses for women 90 years later.
• 🎯 Despite nearly all women experiencing hormone decline with age, they lack regulated, evidence-based dosing, unlike men who have over a dozen FDA-approved formulations.
• ⚠️ The FDA has rejected female-dose testosterone attempts, citing insufficient safety data, a stance that overlooks its long history of use in women and higher doses used in transgender men.

Benefits Beyond Libido

• 🧠 Testosterone is a crucial neurohormone vital for mitochondria, nerve function, muscle, bone, and brain health, not just libido.
• 🚀 Improvements in dopamine and blood flow in the brain contribute to enhanced libido, with brain imaging showing increased activity.
• 📈 Studies suggest higher brain testosterone correlates with less dementia, a leading cause of death in women.
• ⚡ New data indicates that adding testosterone can help more women come off SSRIs than estrogen alone, offering an alternative for mood support with fewer side effects.

Regulatory and Equity Failures

• 🚫 The lack of FDA approval means insurance often won't cover testosterone for women, forcing them to use microdosed male products, justify prescriptions, or pay out-of-pocket for less regulated alternatives.
• ⚖️ This situation represents a regulatory and equity failure, as male testosterone products were approved with only six months of safety data, while female formulations face higher hurdles.
• 🌍 While countries like Australia, New Zealand, South Africa, and the UK have government-approved female-dose testosterone, it's often restricted to low sexual desire, further stigmatizing the issue.

Call to Action for the FDA

• ⚡ Dr. Casperson urges the FDA to fast-track female-dose testosterone using the new commissioner's national priority voucher.
• 📄 Simplify regulatory guidance to enable cost-conscious medication development based on established safety data.
• ✅ Approve testosterone for hypogonadism in women, not solely for low desire, and work with the DEA to declassify low-dose testosterone for women.
• 🌟 The goal is to support 108 million women to be energized, focused, and ambitious, enabling them to thrive through midlife and beyond.