FDA Workshop Explores Testosterone Therapy for Menopausal Women Amid Challenges
As menopausal women inquire about testosterone to ease symptoms, they often face roadblocks like insurance denials and dosage uncertainties. No FDA-approved testosterone product exists for women in the U.S.
The FDA held a public workshop to scrutinize the evidence, safety, and research shortcomings concerning testosterone therapy for women in menopause.
Interest in this therapy is rising. Women seek relief from symptoms like low sexual desire, fatigue, and diminished life quality during menopause. An absence of FDA approval means physicians resort to off-label prescriptions and compounded products.
Dr. Kudzai Dombo, a certified obstetrician-gynecologist at Alloy Health, encounters this situation frequently in her Los Angeles practice. Combatting fatigue and a drop in sexual desire are common reasons patients discuss testosterone with their doctors.
Current guidelines approve testosterone therapy only for hypoactive sexual desire disorder (HSDD). Evidence for its impact on energy, mood, bone health, or sleep is limited, though interest remains strong, Dombo notes.
The absence of female-specific testosterone formulations necessitates off-label workarounds like compounded creams or microscaled male gels.
This lack of standardized choices complicates administrative and financial matters. Insurance often rejects coverage, prompting improvisations, a frustration Dombo knows well.
When prescribed testosterone, Dombo faced insurance denial. Her physician proposed compounded cream to bypass paperwork. Not satisfied after trying compounded options, she opted for male gel, finding it more affordable in the long run.
Dosing male products introduces clinical hurdles. Dombo recounted a patient who carefully used a syringe to measure one-tenth of a male gel packet daily. Despite consistent use, hormone levels showed no change, nor did symptoms improve.
Increasing advocacy pushes federal regulators to assess standardized access and scientific backing for female testosterone therapy.
The recent federal meeting marks an important advancement, Dombo claims. Grassroots efforts are driving regulatory consideration.
Dombo stresses, “Sexual health is part of your entire health.” She anticipates regulatory bodies will respond, offering safer, standardized access over time.