Oral administration

14.3.1.1 Unmodified testosterone

Unmodified testosterone as physiologically secreted by the testes would appear to be the first choice when considering substitution therapy. When ingested orally in its unmodified form testosterone is absorbed well from the gut but is effectively metabolized and inactivated in the liver before it reaches the target organs ("first-pass-effect"). Only when a dose of 200 mg is ingested which exceeds 30fold the amount of testosterone produced daily by a normal man, is the metabolizing capacity of the liver overcome. With such doses an increase in peripheral testosterone blood levels becomes measurable and clinical effects can be observed (Daggett et al. 1978; Johnsen et al. 1974; Nieschlag et al. 1975; 1977). The testosterone-metabolizing capacity of the liver, however, is age- and sex-dependent. An oral dose of 60 mg unmodified testosterone does not affect peripheral testosterone levels in normal adult men, but produces a significant rise in prepubertal boys and women (Nieschlag etal. 1977). This demonstrates that testosterone induces liver enzymes responsible for its own metabolism (Johnsen etal. 1976). When the liver is severely damaged its metabolizing capacity decreases. Thus, in patients with liver cirrhosis a dose of 60 mg testosterone (ineffective in normal men) produces high serum levels (Nieschlag etal. 1977).

In hypogonadal men with normal liver function, 400-600 mg testosterone must be administered daily if the patient is to be substituted by oral testosterone (Johnsen 1978; Johnsen et al. 1974), a dose exceeding the testosterone production of a normal man almost 100fold. Aside from being uneconomical, the possibility of adverse effects of such huge testosterone doses cannot be excluded, especially when given over long periods of time as required for substitution therapy. However, in a small group of patients treated for as long as seven years with oral testosterone no serious side-effects were observed (Johnson 1978). Nevertheless, oral administration of unmodified testosterone has not become a generally accepted method for therapeutic purposes.

As a relict of experiments performed last century (see 14.1), preparations containing animal testis or plant extracts or dried organ powder are still being manufactured and are available on the market. Although synthesized in the testis, the testosterone content of these preparations is negligible since the testis, in contrast to other endocrine glands (such as the thyroid), does not store its hormonal products (Cussons et al. 2002). Moreover, the testosterone in these orally consumed products cannot become effective for the reasons described above. Such preparations may at best exert placebo effects anddo notbelongto a rational therapeutic repertoire. Similarly, there is no evidence that ingestion of animal testes as food has endocrine effects.

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