Women Turn to Testosterone for Menopause Symptoms Amidst Treatment Uncertainty

Women seeking testosterone therapy to alleviate menopause symptoms like low sexual desire are encountering significant hurdles, including insurance rejections and uncertainty surrounding appropriate dosages, as no testosterone product is currently FDA-approved for female use in the United States.

The Food and Drug Administration (FDA) held a public workshop on Thursday to review the existing evidence, safety data, and research gaps related to testosterone therapy for menopausal women. This meeting comes as interest in the treatment grows among women experiencing symptoms such as fatigue, reduced quality of life, and diminished libido.

Physicians often find themselves prescribing testosterone off-label or relying on compounded formulations due to the lack of FDA-approved options. Dr. Kudzai Dombo, an obstetrician-gynecologist and Menopause Society-certified practitioner, stated that this is a daily occurrence in her practice. She noted that after patients are established on standard hormone replacement therapies, their next question is frequently about testosterone.

While women may hear about a broad range of potential benefits from social media and peers, current evidence-based guidelines support testosterone therapy primarily for hypoactive sexual desire disorder (HSDD). Evidence for its use in improving energy, mood, bone health, or sleep remains limited, though many patients are eager to explore these secondary benefits.

The absence of a female-specific formulation forces physicians to adopt workarounds. These typically involve using custom compounding pharmacies or carefully micro-dosing FDA-approved male testosterone gels. This method requires patients to meticulously measure out the medication at home, a process that can be prone to error.

These off-label approaches create administrative and financial challenges. Insurance companies often deny coverage for off-label treatments, compelling clinicians and patients to improvise. Dombo shared her own experience where her insurance denied coverage for prescribed testosterone, leading her physician to recommend a compounded cream. She found that a 10-month supply of male gel packets, purchased with a discount coupon, was more affordable than a single month of compounded cream.

Dosing male products for female patients also presents clinical difficulties. Dombo described a patient who precisely measured one-tenth of a male gel packet daily for three months, yet follow-up bloodwork showed no change in hormone levels and no symptom relief.

"We're left to kind of decide, 'Well, what now?' It's all experimentation... 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," Dombo said.

The recent FDA meeting is seen as a significant step forward, with Dombo attributing the regulatory action to persistent advocacy from patients and clinicians. "We're not going to stop knocking on the door, because there are several of us who believe that women deserve to be able to have access to just what they need," she stated.

Dombo emphasized that sexual health is an integral part of overall health and expressed optimism that regulatory agencies will adapt to support safer, standardized access to testosterone therapy for women.