Long-term administration of testosterone undecanoate every 3 months for testosterone supplementation in female-to-male transsexuals

Context: The most common treatment regimen in female-to-male transsexuals is administration of short-acting testosterone esters im every 2 wk. Objective: Our objective was to report the effects of administering long-acting testosterone undecanoate every 3 months on hormonal and clinical changes, mortality, morbidity, and safety during the first year of treatment in female-to-male transsexuals. Design: This was a 1-yr observational study. Setting: The setting was an outpatient department at a university hospital. Patients: A total of 35 female-to-male transsexuals completed the first year of observation, whereas two patients discontinued the treatment regimen due to serious hypertension. Intervention: The intervention was 1-yr im treatment with longacting testosterone undecanoate every 3 months. Main Outcome Measures: Gonadotropins, steroid hormones, liver enzymes, lipids, blood and coagulation parameter, body mass index, blood pressure, bone mineral density, and endometrium thickness were measured at the beginning of cross-sex hormone treatment and after 12 months. The mortality, morbidity, adverse effects, and desired clinical changes were recorded. Results: There was a significant decrease in LH, prolactin, SHBG, high-density lipoprotein levels, and endometrium thickness, and a significant increase in body mass index, systolic and diastolic blood pressure, total testosterone and calculated androgens, triglycerides, hemoglobin, and hematocrit levels. No mortality was observed. Two cases of hypertension were noted. The patients reported a desirable increase in libido and clitoral growth. Acne was observed in five patients ( 14.3%). Conclusions: The treatment of female-to-male transsexuals with long-acting testosterone undecanoate may be a feasible and safe option for testosterone augmentation in these subjects. However, monitoring of blood pressure should not be ignored during the treatment, to identify patients liable to develop hypertension.