Testosterone propionate

Single-dose pharmacokinetics of 50 mg testosterone propionate after intramuscular injection to seven hypogonadal patients and the best-fitted pharmacokinetic profile are shown in Fig. 14.4 (Nieschlag et al. 1976). Maximal testosterone levels in the supraphysiological range were seen shortly after injection (40.2 nmol/l, tmax = 14 h). Testosterone levels below the normal range were observed following day 2 (57 h) after injection. The calculated values for AUC were 1843 nmol * h/l, forMRT 1.5 d and 0.8 d for terminal half-life (Table 14.2).

Based on single-dose pharmacokinetic parameters, a multiple-dose pharmacoki-netic simulation was performed. Expected testosterone serum concentrations after multiple dosing of 50 mg testosterone propionate twice per week (e.g. injections Mondays and Thursdays, 8.00 h) are shown in Fig. 14.5. Shortly after injection high supraphysiological testosterone serum concentrations of up to 45 nmol/l are observed. At the end of the injection interval (three and four days, respectively)

Injections Propionate

Fig. 14.5 Multiple-dose pharmacokinetics of testosterone propionate after injection of 50 mg testosterone propionate twice per week (e.g. Mondays and Thursdays). Solid curve, pharmacokinetic simulation; broken lines, range of normal testosterone values.

Fig. 14.5 Multiple-dose pharmacokinetics of testosterone propionate after injection of 50 mg testosterone propionate twice per week (e.g. Mondays and Thursdays). Solid curve, pharmacokinetic simulation; broken lines, range of normal testosterone values.

testosterone serum concentrations below the lower range of normal testosterone values are projected (7 nmol/l and 3 nmol/l, respectively).

Judged by the data from pharmacokinetic analysis and simulation, administration of testosterone propionate is not suitable for substitution therapy of male hypogonadism because of its short-term kinetics resulting in wide fluctuations of testosterone serum concentrations and maximal injection intervals of three days for the 50 mg dose.

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