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Jump to Key Points Sept 17 (Reuters) - US health regulators weighing testosterone use in menopausal women at a public meeting on Thursday were told by some experts that a female-specific product was needed while others pointed to gaps in evidence on the hormone's broader benefits and long-term safety.
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.
In the opening hours, 10 speakers, including government officials and clinicians, discussed testosterone levels in women, potential uses to address menopause symptoms and safety concerns.
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.
- FDA to review testosterone in menopausal women: benefits, risks, dosing, female role.
- No FDA-approved testosterone therapy for women; off-label use common for HSDD.
- Clinicians use low-dose male products or compounded formulations; female-specific product could standardize dosing.
- Evidence strongest for HSDD; no proof for ↑ muscle, bone, mood, or cognition.
- Safety gaps persist: long-term CV/breast cancer risk unknown; androgenic AEs include acne, hirsutism, voice deepening.
The UK, Australia, New Zealand and South Africa have approved or licensed testosterone products specifically for women.
Assistant Secretary for Health Admiral Brian Christine in his opening remarks said it was unacceptable that US women lack a testosterone therapy approved specifically for them while such treatments are available in Australia.
"Something's wrong with that," he said, urging the FDA to "listen to the women who need an approved testosterone product" and "get this done."
Physicians who prescribe testosterone to women typically rely on low doses of products approved for men, often dividing existing products such as AbbVie's AndroGel and Keenova Therapeutics' Testim, or on compounded formulations.
Dorothy Fink, deputy director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said women deserved testosterone options "formulated and dosed specifically for them."
But some experts said the need for a female-specific product does not resolve questions about how broadly testosterone should be used.
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 or general well-being. Oral testosterone is not recommended because of unfavorable effects on cholesterol levels, she said.
Patil called for "generating the evidence necessary to fully and more comprehensively characterize the benefit and the risk."
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.
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.
The public comment period following the FDA testosterone workshop closes on October 19.
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 only strong for HSDD.
The FDA has approved non-testosterone options like Sprout Pharmaceuticals' Addyi and Cosette Pharmaceuticals' Vyleesi for certain patients with HSDD.
"We believe postmenopausal women deserve access to additional treatment options to address concerns related to sexual function," Cosette Pharmaceuticals said in an email.
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.
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.
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.
(Reporting by Siddhi Mahatole and Padmanabhan Ananthan in Bengaluru; Editing by Mrinalika Roy and Bill Berkrot)
