FDA Explores Testosterone Therapy for Menopausal Women

The lack of FDA-approved testosterone products for women in the United States has created hurdles for those seeking relief from menopause symptoms like low sexual desire and fatigue. On Thursday, the Food and Drug Administration (FDA) organized a public workshop to evaluate evidence and research gaps regarding testosterone therapy for menopausal women.

Interest in testosterone therapy has grown among women seeking treatment for symptoms affecting their quality of life. However, without FDA-approved options, physicians resort to off-label version prescribing and compounded formulations. Dr. Kudzai Dombo, an obstetrician-gynecologist in Los Angeles, confirmed this increasing interest in testosterone therapy among her patients, who often inquire about it after estrogen and progesterone treatments.

Despite widespread curiosity fueled by social media and anecdotal claims, guidelines recommend testosterone only for hypoactive sexual desire disorder (HSDD). The clinical evidence supporting its use for energy, mood, or bone health remains limited. In the absence of a female-specific product, doctors must navigate off-label methods, choosing between compounded creams or micro-dosing FDA-approved male gel packets.

“When I was prescribed testosterone, my insurance denied coverage,” Dombo shared. “I opted for a compounded cream to avoid administrative issues.”

Dosing challenges arise with male products. Dombo recounted a patient who, after precise daily measurements, saw no change in hormone levels or symptom relief in three months. Such cases underscore the complexity of adapting male products for female use.

Patient advocacy and medical professional advocacy have prompted federal regulators to examine pathways for standardized testosterone access for women. Dombo sees this federal meeting as a significant step toward addressing these needs. Grassroots efforts have led to regulatory attention, with advocates seeking equitable access to treatments.

“Sexual health is part of your entire health,” Dombo stressed. She remains optimistic that regulations will evolve to facilitate safer access to testosterone therapy.

Fox News Digital’s lifestyle writer, Khloe Quill, contributes to discussions on health, travel, and lifestyle topics.