AB - BACKGROUND: Danazol, a drug extensively used in the management of hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE), has various side effects. This study investigated the virilizing actions of this drug in 31 danazol-treated female patients with HAE-C1-INH. We compared our findings with those of healthy controls and with literature : The patients were interviewed individually about the type and severity of the virilizing effects, as well as about their satisfaction with danazol : The average duration of danazol treatment was years [2 to 23] and its mean daily dose was mg [33 to 200]. The most common adverse effects were hirsutism (n=14), weight gain (n=13), and menstrual disturbances (n=8). The severity of danazol adverse effects did not differ by duration of treatment or by daily drug dose. The mean level of patient satisfaction with the treatment was high. The comparison of age-matched healthy controls and of HAE-C1-INH patients receiving danazol did not demonstrate a statistically higher incidence of any of the monitored symptoms in the danazol : Our findings indicate that long-term danazol treatment - using the lowest effective dose - has only a mild virilizing effect.
Patients applied an ANDRODERM 4 mg/day system around 10 . once daily for 14 days, and then were titrated up to 6 mg/day or down to 2 mg/day according to a morning serum testosterone concentration obtained at 6 . on Day 8. Out of 36 patients who entered the study, 31 (86%) patients remained on the 4 mg/day dose, 4 (11%) were titrated downward to 2 mg/day, and 1 (3%) was titrated upward to 6 mg/day based on the Day 8 testosterone concentrations. The one patient that was titrated to 6 mg/day discontinued from the study for a non-safety related reason. Of the patients who were receiving ANDRODERM 5 mg/day prior to study entry (n = 11), 10 remained at 4 mg/day after titration, and 1 was titrated down to the 2 mg/day dose.
Alkaline phosphatase, hemoglobin and hematocrit, and creatinine may vary depending on the patient's current sex hormone configuration. Several factors contribute to these differences, bone mass, muscle mass, number of myocytes, presence or lack of menstruation, and erythropoetic effect of testosterone. Many transgender men do not menstruate, and those with male-range testosterone levels will experience an erythropoetic effect. As such an amenorrheic transgender man taking testosterone, registered as female and with hemoglobin/hematocrit in the range between the male and female lower limits of normal, may be considered to have anemia, even though the lab report may not indicate so. Conversely, the lack of menstruation, and presence of exogenous testosterone make it reasonable to use the male-range upper limit of normal for hemoglobin/hematocrit. Using the male-range upper limit of normal for alkaline phosphatase and creatinine may also be appropriate for transgender men due to increased bone and muscle mass, respectively. In these cases the provider should reference the male normal ranges for their lab.