The US Food and Drug Administration is examining testosterone therapy for women as more menopausal women turn to the hormone for symptom relief.
At a public meeting on Thursday, doctors, researchers and government officials discussed possible benefits, dosing and long-term safety. The FDA said the meeting could help guide future research and drug development.
The discussion comes as testosterone prescriptions for women continue to rise. Reuters reported that prescriptions increased 146% between January 2023 and July 2026, although doctors mainly prescribe the hormone off-label for low sexual desire.
No FDA-Approved Testosterone Product for Women
The US currently has no testosterone product specifically approved for women.
Doctors who prescribe testosterone often use low doses of products designed for men. They may also prescribe compounded formulations.
That creates practical problems because female patients may need doses that differ significantly from standard male products.
Meanwhile, countries including the UK, Australia, New Zealand and South Africa have approved or licensed testosterone products specifically for women.
US officials and some clinicians say women should have access to products designed with female dosing and safety guidance in mind.
Experts Debate the Evidence
However, specialists disagree about how widely testosterone should be used.
Rajita Patil of UCLA’s Comprehensive Menopause Care Program said current evidence supports testosterone for postmenopausal women with hypoactive sexual desire disorder, or HSDD.
She said evidence remains insufficient to recommend testosterone for broader goals such as improving mood, cognition or general wellbeing.
The Menopause Society and several other medical organizations similarly support testosterone primarily for HSDD in postmenopausal women.
As a result, researchers are calling for more studies before doctors expand its use to other menopause-related symptoms.
Safety Remains a Major Question
Long-term safety represents another major issue for regulators.
The FDA has reviewed testosterone for use in women several times but has not approved a female-specific product. Experts have raised questions about cardiovascular health, breast cancer and other possible risks.
Doctors also warn that excessive testosterone exposure can cause acne and increased facial or body hair.
In some cases, effects such as voice deepening and hair loss may become permanent.
Women with a history of breast cancer are generally advised against testosterone because the hormone can convert into estrogen in the body, which may affect some hormone-sensitive cancers.
Social Media Fuels Interest
Interest in testosterone therapy for women has also grown alongside social media claims.
Online discussions often promote testosterone for energy, muscle strength, bone health, cognition and overall wellbeing.
However, specialists say the strongest evidence currently relates to treating HSDD in postmenopausal women. They say evidence for many of the broader claims remains limited.
At the FDA meeting, hundreds of public comments included women describing improvements in libido, energy and quality of life while using testosterone. Those personal experiences, however, do not replace controlled clinical evidence.
More Research Is Underway
Researchers are now studying testosterone in a range of areas involving women’s health.
More than 30 clinical trials are underway or planned to examine testosterone use for different conditions in women, according to Reuters.
Some researchers are also exploring whether lower-dose formulations could provide more consistent treatment while addressing safety concerns.
The FDA has indicated that manufacturers could potentially use data from testosterone products approved in other countries. However, companies would still need to meet US standards for approval.
Public Comments Remain Open
The FDA’s public discussion is not an approval of testosterone for women.
Instead, regulators are using the process to examine the available evidence and identify areas where additional research is needed.
The public comment period following the workshop remains open until October 19.
For now, the debate centers on two questions: whether women need a testosterone product specifically designed for them and how much evidence is necessary to establish its benefits and long-term safety.
As research continues, testosterone therapy for women remains an active area of medical and regulatory discussion rather than a broadly FDA-approved treatment for menopause.
