When women consult their doctors about using testosterone to alleviate menopause symptoms, they often face hurdles such as insurance denials, confusing alternatives, and uncertain dosages. This is largely because there are currently no FDA-approved testosterone products specifically for women in the United States.
Recently, the Food and Drug Administration (FDA) held a public workshop to discuss the safety, evidence, and research gaps related to testosterone therapy for women experiencing menopause. Interest in such therapies has surged, as many women are looking for solutions for issues like low sexual desire, fatigue, and a decrease in their overall quality of life. However, the absence of FDA-sanctioned options has resulted in physicians often prescribing testosterone off-label and using compounded formulations instead.
Dr. Kudzai Dombo, who specializes in obstetrics and gynecology and is certified in menopause practices, notes that she sees the challenges associated with this issue regularly at her clinic in Los Angeles. Patients typically inquire about testosterone therapy right after starting standard estrogen and progesterone treatments. “The immediate next question is, do I need testosterone?” she shared with Fox News Digital.
While women are increasingly hearing about potential benefits, partly through social media and personal circles, the current clinical guidelines only endorse testosterone therapy for one condition: hypoactive sexual desire disorder (HSDD), which indicates a persistently low sexual drive.
Evidence supporting testosterone’s effectiveness for other concerns—like energy levels, mood enhancement, bone health, and sleep disorders—is still rather limited. Yet, many patients are eager to explore those possibilities, as Dombo explains.
Because there isn’t a testosterone product specifically designed for women, doctors often have to find workarounds, which may involve using compounded creams or adjusting dosages of FDA-approved male hormone gels. This situation poses administrative and financial challenges. Since testosterone therapy for women is typically prescribed off-label, many insurance companies deny coverage, leaving both patients and doctors to navigate these complexities. Dombo recounted her own experience when her insurance did not cover testosterone, leading her to try compounded cream first, despite expressing a desire for the gel instead.
With a discount coupon, she ultimately discovered that a 10-month supply of male gel packs turned out to be cheaper than a single month of compounded cream. “It’s just an example,” she said, “of how we have to adapt to a system that has not supported patients when it comes to access to testosterone therapy.”
Dosing male products can be tricky as well. One of Dombo’s patients meticulously measured a one-tenth dose from a male gel packet each day using a syringe, but despite this careful approach, follow-up tests showed no increase in hormone levels and no symptom improvement after three months.
As advocacy from both patients and healthcare professionals continues to grow, federal regulators are starting to take a closer look at the needs and evidence surrounding female testosterone therapy. “We’re left to kind of decide, ‘Well, what now?’” Dombo stated, acknowledging the experimental nature of current practices. “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.”
The recent federal meeting is seen as a significant breakthrough, according to Dombo, who believes that persistent advocacy from patients and clinicians is driving regulatory change. “We’re not going to stop knocking on the door because there are several of us who believe that women deserve access to just what they need,” she said, emphasizing the connection between sexual health and overall well-being. Dombo remains hopeful that regulatory bodies will eventually provide standardized access to safer, more effective treatments.
