Sponsored by an educational grant from Schering
Here we report on the long-term results in an open-label, randomized, prospective clinical trial investigating a novel long-acting intramuscular testosterone undecanoate (TU) formulation, in 40 hypogonadal men. During the first 30 weeks, patients were randomly assigned to receive either standard treatment with 250 mg testosterone enanthate (TE) im. every 3 weeks (n=20) or 1000 mg TU im. every 6 to 9 weeks (n=20).
After the comparative study, a one-arm follow-up study was started and all men received 1000 mg TU every 12 weeks. This regimen resulted in stable mean serum trough levels of testosterone (from 14.9±5.2 to 16.5±8.0 nmol/L) and estradiol (from 98.5±45.2 to 80.4±14.4 Pmol/L). Haemoglobin and hematocrit levels significantly increased over the observed 30-week comparative study period (haemoglobin: from 14.4±1.0 g/dL to 15.7±1.2 g/dL [TU] and from 14.7±0.8 g/dL to 15.9±1.1 g/dL [TE]; hematocrit: from 43.4±3.0 % to 46.8±3.3 % [TU] and 44.4±2.2 % to 47.8±3.0 % [TE]).
During prolongation of the study, haemoglobin and hematocrit remained stable. Total serum cholesterol concentrations declined from 235.3±46.7 mg/dL to 215.3±36.8 mg/dL (TU) and from 235.5±54.0 mg/dL to 220.9±55.7 mg/dL (TE); LDL-cholesterol concentration from 158.8±45.4 mg/dL to 148.6±39.1 mg/dL (TU) and from 158.7±51.0 mg/dL to 153.4±54.3 mg/dL (TE). Total and LDL-cholesterol concentrations decreased further under long-term therapy with TU (to 202.4±35.7 mg/dL and to 134.9±35.7 mg/dL).
In both treatment groups, serum PSA levels rose slightly after 30 weeks to levels of 0.6-0.7 mg/L remaining stable during long-term administration of TU. In summary im. TU administration every 12 weeks is a safe and efficient therapy for male hypogonadism.
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