By Mrinalika Roy
Sept 15 (Reuters) - Women increasingly turning to testosterone therapy to manage menopause symptoms are running into unexpected prescription delays and denials at pharmacies, according to interviews with more than half a dozen doctors, nurses and patients.
There is no U.S.-approved testosterone product for women, although its off-label use is on the rise, primarily to treat persistently low sexual desire related to menopause, the only condition for which medical guidelines and evidence
of efficacy currently exist.
Some clinicians are also prescribing it for menopause-related symptoms such as fatigue and loss of muscle strength, despite a lack of medical guidance for that use.
The Menopause Society and half a dozen other medical organizations only back testosterone use for hypoactive sexual desire disorder in menopausal women.
"We do not have any evidence in women that it will improve muscle mass or bone density or mood or well-being or really any other metric," said Dr. Stephanie Faubion, director of Mayo Clinic's Center for Women's Health and medical director of The Menopause Society.
"What testosterone is being touted for in the lay public and on social media is not really what we have data for," she said.
SURGING PRESCRIPTIONS
Testosterone's rise comes as more women turn to hormone therapy overall, also driven by social media and, more recently, by the FDA, which backed estrogen and progesterone use for menopause symptoms as safe and effective. Some clinicians prescribe testosterone alongside these therapies.
An exclusive data analysis for Reuters by healthcare analytics firm Truveta shows the rate of women receiving a testosterone prescription jumped 146%, nearly tripling, from January 2023 to July 2026.
The U.S. Food and Drug Administration will hold a public workshop on Thursday to review evidence for testosterone use in menopausal women, which has been promoted by Health Secretary Robert F. Kennedy Jr. and Defense Secretary Pete Hegseth, who has made an issue of testosterone levels among the troops.
While healthcare providers can prescribe approved medicines any way they see fit, an FDA spokesperson said these off-label uses have not been evaluated by the agency for safety, efficacy or dosing.
WORKAROUNDS FOR WOMEN
With no approved testosterone for women, patients must divide packaged versions designed for men often at many times the doses they're seeking.
Jennifer Lanoff, a women's health nurse practitioner in Washington, D.C., said Amazon Pharmacy rejected prescriptions from her practice for the first time this year.
"We've done (off-label testosterone prescriptions) forever. It's clinical guidelines recommended. Amazon has not given us a problem before," she said. "I don't know exactly what happened or why they rejected. They say it was a new policy."
Lanoff said she has had some success rewriting prescriptions under which patients discard leftover gel rather than splitting doses for later use.
Amazon Pharmacy said it does not dispense some testosterone prescriptions that require women to customize doses in order to ensure safe and compliant dispensing. It added that the policy is not specific to testosterone or based on a patient's sex or gender identity.
The company said it refers customers to compounding pharmacies that mix ingredients for specialized doses.
Compounded testosterone can cost about $100 for a three-month supply compared with $30 after discounts for a 10-month supply at a commercial pharmacy, Lanoff said.
Most insurance companies do not cover testosterone for women, the doctors, nurses and patients said.
Magen Price, a nurse practitioner and founder of Mystic Valley Sexual Wellness, said more than one-third of the 80 patients in her practice who currently use testosterone have encountered issues with their prescriptions, including at CVS and Walgreens pharmacies.
The issues that began last year have worsened, Price told Reuters.
When Amy Swan, a 55-year-old graphic designer outside Boston, tried to fill her first testosterone gel prescription in March, she expected a simple pharmacy visit.
Instead, she spent weeks trying to get a pharmacy to honor a GoodRx discount coupon that would reduce the cost by 25%.
"Hours of my time were lost just being able to get this one prescription," Swan said.
CVS said its pharmacies regularly fill prescriptions for topical testosterone gel for women. Other retailers with large pharmacies including Walgreens, Costco and Walmart did not respond to requests for comment. Kroger declined to comment.
Kevin Schipper, a pharmacist and director of product lifecycle management at consulting firm ProPharma, said pharmacies may decline prescriptions due to concerns over dosing accuracy and medication safety, as well as stability, storage and contamination if single-use packaging is opened and reused.
Because it is a controlled substance — similar to aspirin with codeine — each state also has record-keeping requirements for the government.
TRIALS FOR SAFETY
Over 30 trials studying testosterone use for various health conditions in women are underway or planned, according to ClinicalTrials.gov, including a Marius Pharmaceuticals-sponsored sexual dysfunction trial due to start as soon as later this year.
Aviva Bio is developing a next-generation testosterone product that would address breast cancer risk associated with use of the hormone.
Products currently used by women include branded and generic testosterone gels, such as AbbVie's AndroGel, Keenova Therapeutics' Testim and Upsher-Smith's Vogelxo.
Upsher-Smith declined to comment on whether it plans to develop testosterone products specifically for women. AbbVie and Keenova did not respond to requests for comment.
Cynthia Stuenkel, a clinical professor of medicine at the University of California, San Diego, said she hopes the FDA will prioritize evaluating a testosterone product designed for women.
"This would certainly ease the ability of clinicians to more confidently prescribe testosterone and for women to more easily and confidently use testosterone specifically dosed for them," she said.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Caroline Humer and Bill Berkrot)
