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Testosterone enanthate is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus testosterone enanthate can be given at intervals of two to four weeks. Testosterone in plasma is 98 percent bound to a specific testosterone-estradiol binding globulin, and about two percent is free. Generally, the amount of this sex-hormone binding globulin (SHBG) in the plasma will determine the distribution of testosterone between free and bound forms, and the free testosterone concentration will determine its half-life. About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites; about six percent of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. There are considerable variations of the half-life of testosterone as reported in the literature, ranging from 10 to 100 minutes. Local tolerance studies following intramuscular administration showed that testosterone enanthate does not increase the irritant effect already caused by the solvent alone. The solvent of Testosterone Enanthate has been used for many years in numerous formulations for human use. In this time no local irritant effects have been observed which could object to its further use. Investigations using the oily solvent contained in Testosterone Enanthate gave no indications of a sensitising effect. Additional investigations into the sensitising effect of testosterone enanthate have not been carried out. Many years of clinical experience have shown only sporadic cases in which allergenic reactions have been suspected. No clear sensitising effect has been proven. Fertility studies into germ cell damage have not been carried out with Testosterone Enanthate. Such studies were not considered to be necessary since long-term systemic tolerance studies gave no indication of toxic damage to the testicles, but only a centrally related inhibition of the spermatogenesis and oogenesis. On the other hand the temporary inhibition of spermatogenesis following treatment with 250 mg Testosterone Enanthate in humans gave no indication that sperm cells are damaged in any way which might lead to malformations or impairment of fertility in the offspring. Administration of Testosterone Enanthate is contraindicated during pregnancy due to the possibility of virilisation of the female foetus. However, investigations into embryotoxic, in particular teratogenic, effects gave no indication that further impairment of organ development is to be expected. |
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