Andriol contains testosterone undecanoate, a fatty acid ester of the natural hormone testosterone. Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life, testosterone is essential for the functioning of the testes and accessory structures, and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function.
Treatment of hypogonadal men with Andriol results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of sex hormone-binding globulin (SHBG). In males with primary (hypergonadotropic) hypogonadism, treatment with Andriol results in a normalization of gonadotropin levels.
Testosterone replacement therapy in males for primary or secondary hypogonadal disorders e.g. after castration, eunuchoidism, hypopituitarism, endocrine impotence, male climacteric symptoms (e.g. decreased libido, decreased feeling of general well being), certain types of infertility due to spermatogone disorders. Testosterone therapy in men may be indicated in osteoporosis caused by androgen deficiency.
Single administration of 80-160 mg Andriol Testocaps leads to a clinically significant increase of total plasma testosterone with peak levels of approximately 40 nmol/L (Cmax). reached approximately 4-5 hr (tmax) after administration. Plasma testosterone levels remain elevated for at least 8 hrs. Testosterone and dihydrotestosterone are metabolized via the normal pathways.
Dosage should be adjusted according to the response of the individual patient. Usually, an initial dosage of 120-160 mg daily for 2-3 weeks is adequate, followed by a maintenance dosage of 40-120 mg testosterone undecanoate daily.