Off-Label Prescriptions for Women on the Rise

• A current evaluation discovered that testosterone prescriptions for females elevated 146% between January 2023 and July 2026.
• There are at present no FDA-approved testosterone merchandise particularly for females, which may create dosing and prescription entry challenges.
• Present scientific steering helps testosterone remedy for hypoactive sexual want dysfunction (HSDD) in postmenopausal females.
• Extra analysis is required to find out whether or not testosterone offers advantages for different menopause-related issues, resembling fatigue, temper, and muscle power.

Over the previous few years, there was a surge in prescriptions of testosterone for females experiencing menopause, in line with an evaluation by the analysis analytics firm Truveta for Reuters that was printed on September 15. Nonetheless, these outcomes haven’t been printed in a scientific journal.

The rise in prescriptions has additionally come amid reviews of prescription delays and denials at pharmacies.

This can be due partially to the truth that there are at present no testosterone merchandise accredited by the Meals and Drug Administration (FDA) particularly for females, regardless of years of off-label use and evidence supporting testosterone remedy for hypoactive sexual want dysfunction (HSDD) in postmenopausal females.

Nonetheless, on September 17, the FDA called for more data on testosterone remedy for females and inspired producers to conduct research that would help future approval of female-specific merchandise.

Organizations such because the Menopause Society help using testosterone for HSDD in postmenopausal females, however not for different menopause signs.

Nonetheless, Stephanie Faubion, MD, MBA, Director of the Mayo Clinic Middle for Girls’s Well being and Medical Director for The Menopause Society, instructed Healthline that proof doesn’t help using testosterone for many menopause signs.

“There may be proof for its use for hypoactive sexual want dysfunction in postmenopausal girls. Testosterone doesn’t decline particularly with menopause, however declines as a operate of growing old,” she mentioned. “It has not been proven to assist with issues like fatigue, well-being, bone density, muscle mass, or temper.”

Nonetheless, regardless of an absence of supporting proof or guideline suggestions, some clinicians have been prescribing testosterone off-label to assist with fatigue and lack of muscle power.

Sherry Ross, MD, board licensed OB/GYN and Girls’s Well being Skilled at Windfall Saint John’s Well being Middle in Santa Monica, CA, mentioned that testosterone is rather more necessary within the menopause dialog than individuals notice.

“This highly effective hormone helps in promoting muscle power, bone development, libido, balancing temper and power, and decreasing anxiousness. Since menopause negatively impacts all these methods, giving it some consideration might be life altering in perimenopause and menopause,” she added.

Testosterone has lengthy been regarded as a “male” hormone. Nonetheless, females additionally naturally produce testosterone. Testosterone ranges decline with age, however this decline just isn’t particularly brought on by pure menopause.

Faubion additionally acknowledged, “When postmenopausal or late perimenopausal girls use testosterone, it’s crucial that their ranges are maintained within the regular vary for a premenopausal lady.”

HSDD is a common sexual well being situation characterised by persistently low sexual want that causes important private misery.

One study discovered that 52.4% of naturally menopausal females skilled low sexual want, whereas 6.6% had HSDD.

HSDD additionally impacts round 1 in 8 females ages 45–65.

“Testosterone has been shown to extend sexual want and enhance different points of sexual functioning, together with arousal and sexual satisfaction,” mentioned Faubion.

Nonetheless, that is nonetheless thought-about an off-label use of testosterone.

Ross famous that testosterone might be prescribed in varied types, resembling lozenges, ointments, lotions, and gels. She additionally famous that the dose you’re given ought to be fastidiously mentioned along with your healthcare skilled.

That is particularly necessary as a result of there are at present no FDA-approved testosterone merchandise particularly for females. Consequently, clinicians might prescribe merchandise formulated for males at a lot decrease doses.

As a result of merchandise formulated for males might must be divided to offer a decrease dose, some females might have problem getting their prescriptions stuffed.

Nurse practitioners instructed Reuters that they’d had prescriptions rejected by pharmacies, and lots of of their sufferers had hassle getting them stuffed.

Amazon Pharmacy additionally instructed Reuters that it doesn’t dispense some testosterone prescriptions that require females to customise doses as a way to guarantee secure and compliant dishing out. It added that the coverage just isn’t particular to testosterone or based mostly on an individual’s ‌intercourse or ⁠gender identification.

Together with the FDA’s encouragement for extra information and research, there are greater than 30 trials finding out using testosterone for varied well being circumstances in females underway or deliberate, in line with ClinicalTrials.gov.

For instance, Avivo Bio is creating a testosterone remedy designed particularly for females and is finding out its potential results on breast tissue.

“Testosterone ought to not be an afterthought when managing the signs of perimenopause and menopause,” mentioned Ross.

“Extra analysis is required to proceed supporting its advantages past enhancing libido, however the prepare has left the station, and persons are having fun with the journey. Its whole-body advantages shouldn’t be minimized or downplayed.”

Present scientific steering helps testosterone remedy for HSDD in postmenopausal females, whereas extra analysis is required to find out whether or not it offers advantages for different menopause-related issues.