FDA Weighs Testosterone Therapy for Women as Los Angeles Doctors Describe Prescribing Workarounds

The Food and Drug Administration held a public workshop on Thursday to review evidence, safety data and research gaps around testosterone therapy for menopausal women, as growing numbers of patients ask about the treatment despite the absence of any FDA-approved product for female use.

No testosterone product is currently approved for women in the United States, leaving physicians to rely on off-label prescribing and compounded formulations. That gap creates insurance denials, confusing workarounds and guesswork over dosing, according to doctors who treat menopausal patients.

Dr. Kudzai Dombo, a board-certified obstetrician-gynecologist, Menopause Society-certified practitioner and prescribing physician at Alloy Health, said she encounters the problem daily in her Los Angeles practice. Once patients are stabilized on standard estrogen and progesterone regimens, she said, “The immediate next question is, do I need testosterone?”

Although women often hear about a wide range of potential benefits from social media and friends, current evidence-based guidelines support testosterone therapy for only one condition: hypoactive sexual desire disorder, or persistently low sexual desire. Evidence for using it to address energy, mood, bone health or sleep remains limited, Dombo said, even though many patients want to try it for those reasons.

Because there is no female-specific formulation, doctors typically choose between custom compounding pharmacies or having patients micro-dose FDA-approved male gel packets, carefully measuring out small amounts at home.

The off-label status also creates financial and administrative hurdles, since insurers routinely deny coverage. Dombo said she ran into this herself. “When I was prescribed testosterone, my insurance denied coverage, and my physician recommended a compounded cream to avoid the administrative burden,” she said. “I said, ‘Well, I’ve already tried compounded and I actually want to try the gel.'”

Using a discount coupon, she paid out of pocket and found that a 10-month supply of male gel packets cost less 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.

Dosing male products for female patients can also fall short clinically. Dombo described a patient in her private practice who measured out one-tenth of a male gel packet daily using a syringe. After three months of consistent use, follow-up bloodwork showed no change in hormone levels and no symptom relief.

“We’re left to kind of decide, ‘Well, what now?’ 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.”

Dombo said she views the FDA’s workshop as a meaningful step, driven in part by pressure from patients and clinicians pushing for regulatory change. “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.

“Sexual health is part of your entire health,” she added, saying she is hopeful that regulators will eventually move toward safer, standardized access to testosterone therapy for women.