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US health regulators weighing testosterone use in menopausal women at a public \u200cmeeting on Thursday were told by some experts that a female-specific product was needed, while others pointed to gaps in evidence on the hormone\u2019s broader benefits and long-term safety.<\/strong><\/p>\n The meeting, which the US 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.<\/p>\n In the opening \u200bhours, 10 speakers, including government officials and clinicians, discussed testosterone levels in women, potential uses to address menopause symptoms, and safety concerns.<\/p>\n There is no \u200bFDA-approved testosterone therapy for women, despite years of off-label use to treat low sexual desire, known as hypoactive sexual desire disorder, \u2060or HSDD.<\/p>\n The UK, Australia, New Zealand and South Africa have approved or licensed testosterone products specifically for women.<\/p>\n Assistant Secretary for Health Admiral Brian Christine, in his opening \u200bremarks, said it was unacceptable that US women lack a testosterone therapy approved specifically for them while such treatments are available in Australia.<\/p>\n \u201cSomething\u2019s wrong with that,\u201d he \u200bsaid, urging the FDA to \u201clisten to the women who need an approved testosterone product\u201d and \u201cget this done.\u201d<\/p>\n Physicians who prescribe testosterone to women typically rely on low doses of products approved for men, often dividing existing products such as AbbVie\u2019s AndroGel and Keenova Therapeutics\u2019 Testim, or on compounded formulations.<\/p>\n Dorothy Fink, deputy director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said \u200bwomen deserved testosterone options \u201cformulated and dosed specifically for them.\u201d<\/p>\n But some experts said the need for a female-specific product does not resolve questions about how broadly testosterone should \u200bbe used.<\/p>\n Rajita Patil, director of the UCLA Comprehensive Menopause Care Program, said evidence supports testosterone only for postmenopausal women with HSDD, with insufficient data to recommend it for mood, cognition \u200cor general \u2060well-being. Oral testosterone is not recommended because of unfavorable effects on cholesterol levels, she said.<\/p>\n Patil called for \u201cgenerating the evidence necessary to fully and more comprehensively characterize the benefit and the risk.\u201d<\/p>\n Testosterone has been reviewed by the FDA multiple 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.<\/p>\n The FDA\u2019s request for public comments ahead of the meeting attracted hundreds of submissions, many from women describing improved libido, \u200benergy, and quality of life while using \u200btestosterone.<\/p>\n The public comment period following the \u2060FDA testosterone workshop closes on October 19.<\/p>\n EVIDENCE AND SAFETY GAPS<\/strong><\/p>\n 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 only strong \u200bfor HSDD.<\/p>\n The FDA has approved non-testosterone options like Sprout Pharmaceuticals\u2019 Addyi and Cosette Pharmaceuticals\u2019 Vyleesi for certain patients with HSDD.<\/p>\n \u201cWe \u200bbelieve postmenopausal women deserve \u2060access to additional treatment options to address concerns related to sexual function,\u201d Cosette Pharmaceuticals said in an email.<\/p>\n 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 fuel some cancers.<\/p>\n Excessive testosterone exposure can cause acne and increased hair growth, physicians said, while rarer \u2060effects such \u200bas voice deepening and hair loss may be irreversible.<\/p>\n Studies show that testosterone therapy is generally considered \u200bsafe for men with medically diagnosed low levels of the hormone when prescribed and monitored by a doctor.<\/p>\n Last year, the FDA removed the boxed warning about increased cardiovascular risk from testosterone products for men after \u200breviewing post-marketing studies, though the products still carry warnings about increased blood pressure.<\/p>\n<\/div>\n