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When women ask their doctors about taking testosterone to help with menopause symptoms, they can run into insurance rejections, confusing workarounds and dosing guesswork, as no testosterone product is FDA-approved for women in the U.S.
On Thursday, the Food and Drug Administration (FDA) convened a public workshop to examine the evidence, safety and research gaps surrounding testosterone therapy for menopausal women.
Interest in testosterone therapy has grown as more women seek treatment for symptoms such as low sexual desire, fatigue and reduced quality of life during menopause — yet the lack of an FDA-approved product has left physicians relying on off-label prescribing and compounded formulations.
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Dr. Kudzai Dombo, a board-certified obstetrician-gynecologist, Menopause Society-certified practitioner, and prescribing physician at Alloy Health, said she sees this dynamic playing out daily in her own Los Angeles practice.
Interest in testosterone therapy has grown as more women seek treatment for symptoms such as low sexual desire, fatigue and reduced quality of life during menopause, doctors say. (iStock)
Once patients get settled on standard estrogen and progesterone regimens, “The immediate next question is, do I need testosterone?” Dombo told Fox News Digital.
Although women may hear about a wide range of potential benefits on social media and from friends, current evidence-based guidelines support testosterone therapy for only one indication: hypoactive sexual desire disorder (HSDD), or persistently low sexual desire.
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Clinical evidence supporting its use for energy, mood, bone health or sleep remains limited — though many patients are eager to try it for those secondary benefits, according to Dombo.
The absence of FDA-approved female testosterone products forces patients to rely on compounded creams, over-the-counter purchases abroad or micro-dosed male gels. (iStock)
Because no female-specific formulation exists, doctors must navigate off-label workarounds. They typically choose between using custom compounding pharmacies or micro-dosing FDA-approved male gel packets, which patients must carefully measure out at home.
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This lack of standardized options creates administrative and financial hurdles. Because the therapy is off-label, insurance routinely denies coverage, forcing clinicians and patients to improvise — a frustration that Dombo experienced firsthand.
“When I was prescribed testosterone, my insurance denied coverage, and my physician recommended a compounded cream to avoid the administrative burden,” Dombo recalled. “I said, ‘Well, I’ve already tried compounded and I actually want to try the gel.'”
“Sexual health is part of your entire health.”
Using a discount coupon, she paid out of pocket and discovered that a 10-month supply of male gel packets was actually cheaper than a single month of compounded cream.
“It’s just an example, I think, of how we have to adapt to a system that has not supported patients when it comes to access to testosterone therapy,” she said.
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Dosing male products can also present clinical challenges. Dombo described a patient in her private practice who precisely measured out one-tenth of a male gel packet daily using a syringe.
Despite three months of consistency, follow-up bloodwork showed no change in hormone levels, and the patient experienced no symptom relief.
Rising advocacy from patients and medical professionals has pushed federal regulators to officially evaluate standardized access and scientific evidence for female testosterone therapy. (iStock)
“We’re left to kind of decide, ‘Well, what now?'” Dombo said. “It’s all experimentation … We don’t have a set guideline for how to be able to do this for women. We have to rely on the art of medicine.”
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The latest federal meeting represents a critical step forward, according to Dombo, who believes grassroots advocacy from patients and clinicians is forcing regulatory action.
“We’re not going to stop knocking on the door, because there are several of us who believe that women deserve to be able to have access to just what they need,” she said.
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“Sexual health is part of your entire health,” Dombo emphasized, expressing optimism that regulatory agencies will eventually adapt to support safer, standardized access.