Testosterone ester combinations

Testosterone ester mixtures have been widely used for substitution therapy of male hypogonadism (e.g. TestovironRDepot 50: 20 mg testosterone propionate and 55 mg testosterone enanthate; TestovironRDepot 100:25 mg testosterone propionate and 100 mg testosterone enanthate; SustanonR 250: 30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate). These combinations are used following the postulate that the so-called short-acting testosterone ester (e.g testosterone propionate) is the effective testosterone for substitution during the first days of treatment and the so-called long-acting testosterone (e.g. testosterone enanthate) warrants effective substitution for the end of injection interval. However, this assumption is not supported by the pharmacokinetic parameters of the individual testosterone esters. Both testosterone propionate and testosterone enanthate cause highest testosterone serum concentrations shortly after injection (Fig. 14.4 and Fig. 14.6). Accordingly, addition of testosterone propionate to testosterone enanthate only increases the initial undesired testosterone peak and worsens the pharmacokinetic profile that ideally should follow zero-order kinetics (Fig. 14.9). The computer simulation agrees well with the limited published single-dose testosterone values that have been measured in hypogonadal patients treated with the combination of testosterone propionate and testosterone enanthate. Maximal increases ofapproximately 40 nmol/l testosterone over basal values are described one day after intramuscular administration of a testosterone ester combination of 115.7 mg testosterone enan-thate and 20 mg testosterone propionate to three hypogonadal patients (Fukutani etal. 1974).

A comparison of computer-simulated testosterone serum concentrations after multiple-dose injections of TestovironR Depot 100 (110 mg testosterone enanthate and 25 mg testosterone propionate = 100 mg unesterified testosterone) every 10 d and 139 mg testosterone enanthate (= 100 mg unersterified testosterone) every 10 d is shown in Fig. 14.10. As can be expected by the single-dose kinetics of the

Fig. 14.9 Pharmacokinetic profile of TestovironR Depot 100 (110 mg testosterone enanthate and 25 mg testosterone propionate) in comparison to the pharmacokinetics of the individual testosterone esters of the mixture. Curves, pharmacokinetic simulations.

Fig. 14.10 Multiple-dose pharmacokinetics of the testosterone ester mixture TestovironR Depot 100 (110 mg testosterone enanthate and 25 mg testosterone propionate = 100 mg unesterified testosterone, upper panel) every 10 d in comparison to 139 mg testosterone enanthate (= 100 mg unersterified testosterone, lower panel) every 10 d. Solid curves, pharmacokinetic simulations; broken lines, range of normal testosterone values.

Fig. 14.10 Multiple-dose pharmacokinetics of the testosterone ester mixture TestovironR Depot 100 (110 mg testosterone enanthate and 25 mg testosterone propionate = 100 mg unesterified testosterone, upper panel) every 10 d in comparison to 139 mg testosterone enanthate (= 100 mg unersterified testosterone, lower panel) every 10 d. Solid curves, pharmacokinetic simulations; broken lines, range of normal testosterone values.

individual esters, injection of the testosterone ester mixture (upper panel) produces a much wider fluctuation of testosterone serum concentrations relative to injection of testosterone enanthate alone (lower panel). This simulation shows that injections of testosterone enanthate alone produce a more favourable pharmacokinetic profile in comparison to injections of testosterone propionate and testosterone enanthate ester mixtures in comparable doses. For treatment of male hypogonadism there is no advantage in combining the available short- and long-acting testosterone esters.

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