The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use. Provisional Application No. Testosterone, the major circulating androgen in men, is synthesized from cholesterol. Circulating testosterone is metabolized to various keto steroids through two different pathways.
Thus, a number of measurements for testosterone are available from clinical laboratories. There is considerable variation in the half-life of testosterone reported in the literature, ranging from 10 to minutes. Researchers do agree, however, that circulating testosterone has a diurnal variation in normal young men.
Maximum levels occur at approximately to a. The physiological significance of this diurnal cycle, if any, however, is not clear. Male hypogonadism results from a variety of patho-physiological conditions in which testosterone concentration is diminished below the normal range.
The hypogonadic condition is sometimes linked with a number of physiological changes, such as diminished interest in sex, impotence, reduced lean body mass, decreased bone density, lowered mood, and decreased energy levels. Researchers generally classify hypogonadism into one of three types.
Primary hypogonadism includes the testicular failure due to congenital or acquired anorchia, XYY Syndrome, XX males, Noonan's Syndrome, gonadal dysgenesis, Leydig cell tumors, maldescended testes, varicocele, Sertoli-Cell-Only Syndrome, cryptorchidism, bilateral torsion, vanishing testis syndrome, orchiectomy, Klinefelter's Syndrome, chemotherapy, toxic damage from alcohol or heavy metals, and general disease renal failure, liver cirrhosis, diabetes, myotonia dystrophica.
