FDA Workshop Weighs Testosterone Therapy for Menopausal Women as Off-Label Use Climbs
核心洞察
FDA officials told a public workshop that there are no approved testosterone uses for menopausal women, even as off-label prescribing of male-formulated products increases.
Experts said evidence supports testosterone only for postmenopausal women with hypoactive sexual desire disorder (搜索), with insufficient data for mood, cognition or general well-being.
Some speakers, including Assistant Secretary for Health Admiral Brian Christine, called for a female-specific testosterone product, noting approvals already exist in Australia and other countries.
Testosterone therapy is being used increasingly by menopausal women in the United States, but specialists convened at a Food and Drug Administration (搜索) public workshop on Thursday said fundamental questions about long-term safety and the breadth of benefits remain unanswered. The agency said the meeting could help guide future research and drug development.
"There are no FDA-approved uses for testosterone therapy for menopausal women," said Dr. Christina Chang, division director of the division of urology, obstetrics and gynecology in the FDA's Center for Drug Evaluation and Research. She said the agency is aware of increasing off-label use of testosterone among women experiencing menopause.
No Approved Product, Widespread Off-Label Prescribing
Because no testosterone formulation is approved for women in the U.S., clinicians who prescribe the hormone typically do so off-label, using smaller doses of products designed for men. Physicians often divide existing products such as AbbVie's AndroGel and Keenova Therapeutics (搜索)' Testim, or rely on compounded formulations.
The UK, Australia, New Zealand and South Africa have approved or licensed testosterone products specifically for women. Assistant Secretary for Health Admiral Brian Christine said in opening remarks that it was unacceptable for U.S. women to 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."
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."
Evidence Strongest for Low Sexual Desire
Currently, evidence supporting testosterone therapy in women is largely focused on hypoactive sexual desire disorder (搜索) (HSDD), a condition characterized by persistently low sexual desire that causes distress. Workshop speakers said women are seeking testosterone for a much broader range of concerns, including energy and mood, symptoms for which current guidelines do not consider testosterone a treatment.
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."
Interest among menopausal women has grown alongside social media claims that testosterone 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 for certain patients with HSDD: Sprout Pharmaceuticals (搜索)' Addyi and Cosette Pharmaceuticals (搜索)' Vyleesi.
"We believe postmenopausal women deserve access to additional treatment options to address concerns related to sexual function," Cosette Pharmaceuticals (搜索) said in an email.
Safety Questions and Diagnostic Limits
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 (搜索) risks. Testosterone is generally not recommended for women with a history of breast cancer because it can be converted to estrogen in the body, which 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.
Measuring testosterone in women also presents challenges because concentrations are much lower than in men. There is no blood-test threshold that can diagnose whether a woman has a testosterone deficiency.
Studies show that while adult males generally have about 15 times more total testosterone than females, testosterone is the most abundant sex hormone in premenopausal women, produced at roughly three times the rate of estrogen. Levels decline gradually with age, and low levels have been linked to loss of bone density and muscle mass, along with declines in cognition, mood, sexual function and energy. Unlike estrogen, testosterone levels do not suddenly fall at menopause.
"There is a gradual decline in testosterone levels across the premenopausal levels," Dr. Margaret Wierman, professor of medicine at the University of Colorado School of Medicine, told ABC News.
Regulatory Context and Next Steps
The workshop comes amid rising hormone replacement therapy (HRT) use among menopausal women. HRT prescriptions among women ages 50 to 65 rose 72% from 2021 to 2025, according to data from Epic Research. The increase follows the FDA's removal earlier this year of the "black box" warning label from HRT products for menopause, and the subsequent removal of the warning on testosterone products.
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. Testosterone therapy is generally considered safe for men with medically diagnosed low levels of the hormone when prescribed and monitored by a doctor.
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 workshop closes on October 19.
"Menopause is inevitable, women should not have to suffer through it," Chang said. "To best serve the American women we need high-quality data and we are looking forward to working with all the manufacturers to be able to get that data."