Injectables

Testosterone enanthate (TE) and cypionate are testosterone esters administered by biweekly or triweekly deep im injection. The usual recommended dose for hypogo-nadal men is 200 mg in 1 mL oil administered every 2 wk. The pharmacokinetics (PK) of injectable testosterone preparations have been carefully studied (73,74), and the PK of TE is shown in Fig. 2. Serum testosterone levels peak within 1 to 3 d after administration, and gradually decline to a trough after 2 to 3 wk. In many subjects, the peak level of serum testosterone achieved in the first few days after an injection may reach a concentration that is higher than the normal adult male reference range. In some patients, the high peaks and low troughs of serum testosterone levels may result in mood swings and acne. In such patients, the dose may be decreased and frequency of the injections increased, for example, testosterone enanthate may be administered at a dose of 100 mg every 7 to 10 d. Most patients can be taught to self-administer injections.

Several other injectable testosterone preparations are in different stages of development. Testosterone undecanoate was developed and is currently marketed in China for the treatment of hypogonadism (75). The preparation (testosterone undecanoate, 200 mg/mL, 1000 mg per injection) has been used in clinical studies for androgen replacement in hypogonadal men in Europe. After administration of 1000 mg testosterone undecanoate, the peak serum testosterone level occurred in the first or second week and remained within the normal range for as long as 12 wk (76,77). We speculate that if available worldwide, it will be a more acceptable injection for most hypog-onadal men than TE or testosterone cypionate. Testosterone microspheres are testosterone incorporated in biodegradable polylactide glycolide. When administered

Testosterone Cypionate Levels

Fig. 2. Pharmacokinetic profiles of different testosterone preparations. (TE, testosterone enanthate 200 mg im once every 3 wk; T patch, trough levels after application of 5-mg T patch the day before; T gel, trough levels after application of 10-g T gel the day before; sublingual T, levels in a day after taking 5-mg sublingual T 3 times a day). (Data from refs. 84 and 92.)

Fig. 2. Pharmacokinetic profiles of different testosterone preparations. (TE, testosterone enanthate 200 mg im once every 3 wk; T patch, trough levels after application of 5-mg T patch the day before; T gel, trough levels after application of 10-g T gel the day before; sublingual T, levels in a day after taking 5-mg sublingual T 3 times a day). (Data from refs. 84 and 92.)

as a single injection, testosterone microspheres can maintain serum testosterone within the normal range for 10 wk in hypogonadal men (78). Recent studies reaffirmed the long-acting properties of testosterone microsphere injections, with a brief pronounced early peak of serum testosterone followed by low normal testosterone levels for 10 to 11 wk (79).

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