Women seeking testosterone therapy for menopausal symptoms often face challenges. Insurance denials, unclear dosing options, and reliance on off-label prescriptions are common due to the lack of an FDA-approved testosterone product for women in the U.S.
The Food and Drug Administration (FDA) hosted a public workshop to evaluate the evidence, safety, and research gaps surrounding testosterone therapy for menopausal women. This interest has grown as women seek solutions for issues like reduced sexual desire and fatigue.
Dr. Kudzai Dombo, an obstetrician-gynecologist and Menopause Society-certified practitioner, recognizes the need for testosterone therapy at her Los Angeles practice. Patients often inquire about testosterone after settling into estrogen and progesterone treatments.
“The immediate next question is, do I need testosterone?” Dr. Dombo explains.
While social media and peers might highlight various benefits, current guidelines approve testosterone therapy mainly for hypoactive sexual desire disorder (HSDD), characterized by persistent low sexual desire.
Clinical evidence for using testosterone therapy to improve energy, mood, bone health, or sleep is limited. Hence, most female patients explore compounded creams, male gels, or overseas purchases in the absence of FDA-approved products.
The lack of standardized protocols creates hurdles. Off-label status means insurance companies often deny coverage, leading to frustration and improvisation. Dr. Dombo recounted her own experience with insurance denial and the suggestion to use compounded creams.
“I’ve already tried compounded, and I actually want to try the gel,” she said.
She used a discount coupon and found that male gel packets over ten months were cheaper than one month of compounded cream. She sees this as a necessary adaptation in the current healthcare system.
Dosing male gel products can be challenging. Dr. Dombo shared a case where a patient used one-tenth of a packet daily, only to find no hormonal change after three months. This situation highlights the experimental nature of current prescribing practices.
Increasing calls from patients and professionals have prompted federal regulators to explore standardized access and evidence for female testosterone therapy. Dr. Dombo sees the recent meeting as a pivotal step, driven by grassroots advocacy.
“We’re not going to stop knocking on the door,” Dombo said, affirming that women deserve access to necessary treatments.
Dombo stresses, “Sexual health is part of your entire health,” voicing optimism that regulatory adjustments will eventually provide safer, standardized access.
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