Examining Testosterone Therapy for Menopausal Women

Women seeking testosterone therapy for menopause symptoms often face challenges with insurance rejections, complex workarounds, and uncertain dosing. This is due to the absence of an FDA-approved testosterone product for women in the U.S.

The Food and Drug Administration held a public workshop to assess the evidence, safety, and research gaps associated with testosterone therapy for menopausal women. Interest in this treatment has risen as women seek solutions for symptoms like low sexual desire, fatigue, and a decline in life quality during menopause. However, without an FDA-approved product, physicians turn to off-label prescribing and compounded formulations.

Dr. Kudzai Dombo, an obstetrician-gynecologist and Menopause Society-certified practitioner at Alloy Health, observes this trend in her Los Angeles practice. Once patients begin standard estrogen and progesterone regimens, they often question if they need testosterone. Despite hearing about possible benefits from social media and friends, current evidence-based guidelines endorse testosterone therapy only for hypoactive sexual desire disorder (HSDD).

Clinical evidence for its use in energy, mood, bone health, or sleep is limited, yet many patients express a desire to try testosterone for these reasons. The lack of FDA-approved products for women results in reliance on compounded creams, overseas purchases, or micro-dosed male gels.

Physicians navigate off-label options by using custom compounding pharmacies or using minute amounts of male gel packets, which require careful measurement. This absence of standardized options leads to administrative and financial obstacles. Insurance often denies coverage for off-label therapy, causing frustration for both clinicians and patients, as experienced by Dombo.

“When I was prescribed testosterone, my insurance denied coverage, forcing me to use compounded cream or micro-dosed gel,” Dombo shared.

Costs can vary significantly. Dombo noted how a 10-month supply of male gel was cheaper than a single month of compounded cream, reflecting how patients must adapt to a system that lacks support for testosterone therapy access.

Dosing poses clinical challenges. Patients might use a syringe to measure gel accurately yet see no change in hormone levels or symptom relief. Advocacy from patients and professionals is prompting official evaluation of standardized access for female testosterone therapy.

Dombo acknowledged the meeting as a critical step forward, believing grassroots advocacy is driving regulatory action. “We’re not giving up because many believe women deserve access to necessary treatment,” she stated, expressing hope for future support of safer, standardized access.