FDA holds public workshop on testosterone therapy for women
美國食品藥物管理局舉辦女性睪固酮療法公開研討會
更新於: 2026年9月17日 上午01:30
Food and Drug Administration (FDA) hosted a landmark public workshop titled "Testosterone Use in Menopausal Women."
此次會議標誌著解決一項重大醫學灰色地帶的關鍵一步：儘管美國許多停經婦女在使用「非適應症(off-label)」睪固酮，但目前尚無專門為女性設計或訂定劑量的FDA核准睪固酮產品。
This meeting marked a crucial step in addressing a significant medical gray area: while many menopausal women in the U.S. use testosterone "off-label," there are currently no FDA-approved testosterone products specifically designed or dosed for women.
該研討會由FDA女性健康辦公室及藥物評估與研究中心主辦，旨在彌合一般臨床實踐與官方科學證據間的差距。
The workshop, organized by the FDA’s Office of Women’s Health and the Center for Drug Evaluation and Research, aimed to bridge the gap between common clinical practices and official scientific evidence.
來自學術界、克里夫蘭診所及美國國家衛生研究院的專家齊聚一堂，討論關鍵議題，包括睪固酮治療的長期安全性——特別是其對心血管健康和乳癌風險的影響——以及其對情緒、認知和骨骼健康的潛在益處。
Experts from academia, the Cleveland Clinic, and the National Institutes of Health gathered to discuss critical topics, including the long-term safety of testosterone therapy—particularly its impact on cardiovascular health and breast cancer risk—as well as its potential benefits for mood, cognition, and bone health.
透過開放公開意見徵詢至2026年10月19日，FDA正邀請臨床醫師、研究人員及患者分享他們的經驗。
By opening a public comment docket until October 19, 2026, the FDA is inviting clinicians, researchers, and patients to share their experiences.
這種協作努力對於建立未來的監管途徑至關重要，確保女性在停經過渡期間能獲得安全、有效且經充分研究的醫療選擇。
This collaborative effort is essential for establishing future regulatory pathways, ensuring that women have access to safe, effective, and well-researched medical options during the menopausal transition.
