madman
Super Moderator
INTRODUCTION AND OBJECTIVE
Over 2.4 million US men have hypogonadism, defined as serum testosterone (T) levels <300 ng/dL. Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral T replacement therapies provide a route of administration that may be more appropriate for some patients’ needs. We present secondary analyses of T data from a phase 3 study of testosterone undecanoate which is approved in 158, 198, 237, 316, and 396 mg doses, with the goal of demonstrating that a large proportion of patients quickly achieved normal serum T levels.
METHODS
A phase 3, randomized, 12-month study was conducted to assess the safety and efficacy of oral testosterone undecanoate (TU) in 325 hypogonadal men. Men 18 to 75 yearswith morning serum T 300 ng/dL twice in one week were eligible. Eligible patients were randomized to oral TU or transdermal T-gel from Days 0 to 42. The initial oral TU dose was 316 mg TU twice a day (BID) (two 158 mg capsules orally). On Day 30±3 days, serum T sampling was done 4-6h after the morning dose. Serum T concentrations at Day 30 were evaluated for men treated with 316 mg TU BID.
RESULTS
158 men had serum T data. For men achieving serum T <450 and 450 ng/dL on Day 30 after initial dosing, mean baseline T was 234.04 and 218.5, and mean baseline BMI was 30 and 30, respectively. Overall, mean serum T was 874 ng/dL, 91% achieved serum T 300 ng/dL, 77% achieved serum T 450 ng/dL (Figure 1). See Figure 1 for distribution of T levels achieved with initial 316 mgTU BID.
CONCLUSIONS
Overall, 316 mg TU BID quickly and effectively increased serum T concentrations above 450 ng/dL in 77% of hypogonadal men. The wide distribution of serum T concentrations for the same dose (e.g., 23% <450 ng/dL and 27% 1000 ng/dL) suggests that men likely respond differently to T replacement therapy. Future studies and investigations should evaluate patient factors that impact the magnitude of T increases allowing for more individualized titrations.
Over 2.4 million US men have hypogonadism, defined as serum testosterone (T) levels <300 ng/dL. Negative effects associated with hypogonadism include development of metabolic syndrome, increased risk of coronary artery disease, decreased libido, low bone mineral density, and muscle loss. Oral T replacement therapies provide a route of administration that may be more appropriate for some patients’ needs. We present secondary analyses of T data from a phase 3 study of testosterone undecanoate which is approved in 158, 198, 237, 316, and 396 mg doses, with the goal of demonstrating that a large proportion of patients quickly achieved normal serum T levels.
METHODS
A phase 3, randomized, 12-month study was conducted to assess the safety and efficacy of oral testosterone undecanoate (TU) in 325 hypogonadal men. Men 18 to 75 yearswith morning serum T 300 ng/dL twice in one week were eligible. Eligible patients were randomized to oral TU or transdermal T-gel from Days 0 to 42. The initial oral TU dose was 316 mg TU twice a day (BID) (two 158 mg capsules orally). On Day 30±3 days, serum T sampling was done 4-6h after the morning dose. Serum T concentrations at Day 30 were evaluated for men treated with 316 mg TU BID.
RESULTS
158 men had serum T data. For men achieving serum T <450 and 450 ng/dL on Day 30 after initial dosing, mean baseline T was 234.04 and 218.5, and mean baseline BMI was 30 and 30, respectively. Overall, mean serum T was 874 ng/dL, 91% achieved serum T 300 ng/dL, 77% achieved serum T 450 ng/dL (Figure 1). See Figure 1 for distribution of T levels achieved with initial 316 mgTU BID.
CONCLUSIONS
Overall, 316 mg TU BID quickly and effectively increased serum T concentrations above 450 ng/dL in 77% of hypogonadal men. The wide distribution of serum T concentrations for the same dose (e.g., 23% <450 ng/dL and 27% 1000 ng/dL) suggests that men likely respond differently to T replacement therapy. Future studies and investigations should evaluate patient factors that impact the magnitude of T increases allowing for more individualized titrations.
