Easing the burden: exploring the role of long-acting testosterone formulations in gender-affirming care

Long-acting testosterone formulations are essential but infrequently used for gender affirmation. Although not FDA approved in the United States for gender dysphoria, testosterone undecanoate is a long-acting testosterone formulation administered every 10 weeks. Similarly, Testopel is an FDA-approved testosterone pellet implanted subcutaneously every three to six months, which slowly releases testosterone for a long-acting androgenic effect.

A retrospective review was conducted between January 2020 and June 2024. Data was collected through the electronic health record using a standardized Case Report Form and patients were identified using a unique study identifier corresponding to their medical record number. Data was then collected about these patients including sex assigned at birth, gender identity, age, race, insurance coverage type, prior testosterone formulation use, type of LA testosterone used, duration of LA testosterone use, reasons for LA testosterone use, recent testosterone level, and recent hematocrit level.

Thirteen individuals were found. Median age was 37 years (IQR 23, 53), and 54% were White, 15% Latino/Hispanic, 7.7% Asian, 8% Black, 8% Mixed Race, and 8% American Indian. Insurance coverage included 8% Medicaid, 78% private, and 15% Medicare. Most patients (85%) were on testosterone undecanoate while 15% were on Testopel. Median duration of use was 20 months (IQR 5, 102). Formulations prior to switching were 69% short-acting testosterone injections, 23% topical gel, and 8% patches. Findings showed most common reasons for switching to long-acting testosterone formulations were 31% poor self-reported adherence (31%) and intolerance or needle phobia (31%). Median total testosterone level was found to be 403 (IQR 167-689) and median hematocrit of 47.2% (IQR 27.6-48.3).

Many chose LA testosterone to improve adherence, which ultimately would improve patient satisfaction. Although there are no official guidelines recommending short versus long-acting testosterone use, having the availability of long-acting formulations may create space for shared decision-making between patients and providers to best address gender-affirming goals of patients. Barriers may exist in terms of paying for and acquiring long-acting formulations, making a dedicated pharmacy technician or insurance authorization specialist a critical part of a gender health program.