WHAT YOU NEED TO KNOW
- No testosterone product is approved by the FDA specifically for women in the United States.
- Current guidelines support testosterone therapy for hypoactive sexual desire disorder, while evidence for energy, mood, bone health and sleep remains limited.
- Doctors rely on compounded creams or carefully measured doses of male gel products, creating dosing, insurance and financial challenges.
- The FDA convened a workshop to examine evidence, safety concerns and research gaps surrounding testosterone therapy for menopausal women.
=
Women seeking testosterone for menopause symptoms can encounter insurance denials, complicated prescribing workarounds and uncertainty over dosing. No testosterone product is approved by the Food and Drug Administration specifically for women in the United States, leaving physicians and patients to navigate a treatment landscape without standardized female formulations.
On Thursday, the FDA convened a public workshop focused on testosterone therapy for menopausal women. The meeting examined available evidence, potential safety concerns and gaps in research as interest in the hormone continues to rise.
More women are asking about testosterone while seeking help for low sexual desire, fatigue and reduced quality of life during menopause. In the absence of a product approved specifically for them, patients often depend on compounded formulations or prescriptions for products designed for men.
Dr. Kudzai Dombo said these questions arise routinely in her Los Angeles practice. Dombo is a board certified obstetrician and gynecologist, a Menopause Society certified practitioner and a prescribing physician at Alloy Health.
Many patients first establish standard treatment regimens involving estrogen and progesterone. After that, Dombo told Fox News Digital, "The immediate next question is, do I need testosterone?"
Women may hear expansive claims about testosterone from friends or through social media. Current guidelines supported by evidence, however, recommend the therapy for one indication, hypoactive sexual desire disorder, also known as HSDD, which involves persistently low sexual desire.
Evidence for using testosterone to improve energy, mood, bone health or sleep remains limited, according to Dombo. Even so, many patients are interested in trying the hormone in hopes of receiving those secondary benefits.
Without a formulation created specifically for women, doctors generally turn to custom compounding pharmacies or prescribe male gel packets in very small amounts. Patients using the male products may have to carefully measure each dose at home.
The lack of standardized options can create both financial and administrative barriers. Insurance companies routinely deny coverage because testosterone therapy for women is prescribed for a use that has not received FDA approval, forcing patients and clinicians to find alternatives.
Dombo encountered that problem herself. By using a discount coupon and paying out of pocket, she found that male gel packets providing a supply lasting 10 months cost less than one 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," Dombo said. Her experience illustrated how the available route to treatment can depend on pricing and improvised prescribing arrangements.
Dosing products designed for men can also create clinical complications. Dombo described a patient in her private practice who used a syringe to precisely measure one tenth of a male gel packet every day.
The patient followed that routine consistently for three months, but follow up bloodwork showed no change in hormone levels. The patient also experienced no relief from symptoms, leaving Dombo without a standardized next step to follow.
"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."
Patient and clinician advocacy has helped push federal regulators to formally evaluate the evidence and the possibility of standardized access. Dombo described the latest federal meeting as a critical step forward and expressed optimism that regulatory agencies will eventually support safer, more consistent treatment options.
"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. Dombo emphasized the broader significance of the issue, saying, "Sexual health is part of your entire health."
Join the Discussion
COMMENTS POLICY: We have no tolerance for messages of violence, racism, vulgarity, obscenity or other such discourteous behavior. Thank you for contributing to a respectful and useful online dialogue.