2026-09-17 10:04:58 / 路透社
2026年9月9日，美国马萨诸塞州梅尔罗斯，一盒供一个月用量的睾酮凝胶装在包装盒中展示。艾米·斯旺/供图 路透社 购买授权，打开新标签页
- 内容摘要
- 相关企业
- 尽管已多年超适应症使用，美国食品药品监督管理局仍未批准任何针对女性的睾酮疗法
- 女性通常会拆分获批用于男性的药物剂量
- FDA表示此次会议有助于指导未来的研究和药物开发
- 专家表示，相关长期安全性数据仍然有限，包括心血管疾病和乳腺癌风险方面的数据
9月17日（路透社）——美国卫生监管机构将于周四审查更年期女性使用睾酮的科学证据，包括其益处、风险、剂量以及在女性健康中的作用，同时还将听取医生和患者的观点。
美国食品药品监督管理局表示，此次公开会议有助于指导未来的研究和药物开发。而就在此时，越来越多的女性开始使用睾酮来缓解更年期症状。
请订阅屡获殊荣的路透社健康周刊《健康动态》，了解最新的医学突破和医疗保健趋势。点击此处注册。
尽管已有多年超适应症使用睾酮治疗低性欲（即性欲减退症，简称HSDD）的历史，但目前美国仍没有FDA批准的针对女性的睾酮疗法。
去年，FDA在审查上市后研究后，移除了针对男性的睾酮产品关于心血管风险升高的黑框警告，但这些产品仍带有血压升高的警告。
为女性开具睾酮处方的医生通常会使用获批用于男性的低剂量产品，通常会拆分现有药物，如艾伯维的
ABBV.N
安特尔凝胶（AndroGel）和Keenova Therapeutics公司的Testim，或是使用复方制剂。
斯坦福大学妇产科学讲师戴安娜·托多夫博士表示，缺乏针对女性的专用产品给临床医生带来了实际挑战。她指出，获批的产品可以提供标准化的剂量、标签和安全监测指导，还有可能改善保险覆盖范围。
不过，一些专家表示，关键问题仍未得到解决。梅奥诊所女性健康中心主任斯蒂芬妮·福比翁博士表示，仍需要更多的长期安全性数据。
英国、澳大利亚、新西兰和南非已经批准或许可了专门针对女性的睾酮产品。
FDA在会议前公开征求意见的活动收到了数百份提交材料，其中很多来自女性，她们描述了使用睾酮后性欲、精力和生活质量得到改善。
证据与安全缺口
更年期女性对睾酮的兴趣与日俱增，社交媒体上也有相关宣传称其可以改善精力、肌肉量、骨骼健康和认知能力，但专家表示，目前证据最充分的适应症仍是性欲减退症。
“我们没有任何证据表明它可以改善女性的肌肉量、骨密度、情绪或幸福感，或是其他任何指标，”福比翁说道。
斯坦福大学医学院更年期与健康老龄化项目主任凯伦·亚当斯博士表示，FDA已经四次审查睾酮用于女性的情况，但由于缺乏长期安全性数据以及对心血管和乳腺癌风险的担忧，始终未获批准。
FDA已经批准了非睾酮类药物，如Sprout Pharmaceuticals的Addyi和Cosette Pharmaceuticals的Vyleesi，用于特定的性欲减退症患者。
对于有乳腺癌病史的女性，通常不建议使用睾酮，因为睾酮在体内可转化为雌激素，可能会促进部分癌症的生长。
医生表示，过量接触睾酮可能会导致痤疮和多毛症，而更为罕见的副作用如声音变粗和脱发可能不可逆。
研究显示，对于经医学诊断为睾酮水平偏低的男性，在医生处方和监测下使用睾酮疗法通常被认为是安全的。
托多夫和亚当斯正在领导斯坦福大学的MIX-T
试点研究，打开新标签页，该研究旨在考察低剂量睾酮对绝经后女性阴道健康和阴道微生物组的影响。预计将在未来两年内公布研究结果。
悉达·马哈托尔和帕德马纳班·安南坦 班加罗尔报道；米纳利卡·罗伊和比尔·伯克罗特 编辑
我们的准则：汤姆森路透社信任原则。
US regulators to examine testosterone therapy as use by menopausal women rises
2026-09-17 10:04:58 / Reuters
A month’s supply of testosterone gel is displayed in its box in Melrose, Massachusetts, U.S., September 9, 2026. Amy Swan/Handout via REUTERS Purchase Licensing Rights, opens new tab
- Summary
- Companies
- No FDA-approved testosterone therapy exists for women despite years of off-label use
- Women often rely on splitting doses approved for men
- FDA says meeting could help guide future research and drug development
- Experts say long-term safety data remain limited, including on cardiovascular and breast cancer risks
Sept 17 (Reuters) – U.S. health regulators will review the scientific evidence on testosterone use in menopausal women on Thursday, including its benefits, risks, dosing and role in female health, as well as perspectives from doctors and patients.
The public meeting, which the U.S. Food and Drug Administration said could help guide future research and drug development, comes as a growing number of women are turning to testosterone to manage menopause symptoms.
Keep up with the latest medical breakthroughs and healthcare trends with the award-winning Reuters Health Rounds newsletter. Sign up here.
There is no FDA-approved testosterone therapy for women, despite years of off-label use to treat low sexual desire, known as hypoactive sexual desire disorder, or HSDD.
Last year, the FDA removed the boxed warning about increased cardiovascular risk from testosterone products for men after reviewing post-marketing studies, though the products still carry warnings about increased blood pressure.
Physicians who prescribe testosterone to women typically rely on low doses of products approved for men, often dividing existing products such as AbbVie’s
ABBV.N
AndroGel and Keenova Therapeutics’ Testim, or on compounded formulations.
The lack of a female-specific product creates practical challenges for clinicians, said Dr. Diana Tordoff, an instructor in obstetrics and gynecology at Stanford, noting that an approved product could provide standardized dosing, labeling and safety-monitoring guidance and potentially improve insurance coverage.
Still, some experts say key questions remain unresolved. More long-term safety data are needed, said Dr. Stephanie Faubion, director of Mayo Clinic’s Center for Women’s Health.
The United Kingdom, Australia, New Zealand and South Africa have approved or licensed testosterone products specifically for women.
The FDA’s request for public comments ahead of the meeting attracted hundreds of submissions, many from women describing improved libido, energy and quality of life while using testosterone.
EVIDENCE AND SAFETY GAPS
Interest in testosterone among menopausal women has grown alongside claims on social media that it can improve energy, muscle mass, bone health and cognition, though specialists say the evidence is strongest for HSDD.
“We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric,” Faubion said.
Dr. Karen Adams, director of Stanford Medicine’s Program in Menopause and Healthy Aging, said testosterone has been reviewed by the FDA four times for use in women but has never been approved because of a lack of long-term safety data and concerns about cardiovascular and breast cancer risks.
The FDA has approved non-testosterone options like Sprout Pharmaceuticals’ Addyi and Cosette Pharmaceuticals’ Vyleesi for certain patients with HSDD.
Testosterone is generally not recommended for women with a history of breast cancer because it can be converted to estrogen in the body that can drive some cancers.
Excessive testosterone exposure can cause acne and increased hair growth, physicians said, while rarer effects such as voice deepening and hair loss may be irreversible.
Studies show that testosterone therapy is generally considered safe for men with medically diagnosed low levels of the hormone when prescribed and monitored by a doctor.
Tordoff and Adams are leading Stanford’s MIX-T
pilot study, opens new tab examining how low-dose testosterone affects vaginal health and the vaginal microbiome in postmenopausal women. Results are expected within the next two years.
Reporting by Siddhi Mahatole and Padmanabhan Ananthan in Bengaluru; Editing by Mrinalika Roy and Bill Berkrot
Our Standards: The Thomson Reuters Trust Principles.
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