High-strength testosterone undecanoate compositions

A method for replacement therapy in a male having a condition associated with a deficiency or absence of endogenous testosterone said method comprising:

• (a) orally administering to a male identified as having a morning serum testosterone level below normal, a daily dosing regimen of a pharmaceutical composition in one capsule in the morning and in one capsule in the evening, with food, said pharmaceutical composition comprising about 18 weight % (wt %) to about 25 wt % testosterone undecanoate and a carrier comprising oleic acid, polyoxyl 40 hydrogenated castor oil, and borage seed oil, that provides about 450 mg to 480 mg testosterone undecanoate to said male per day;
• and
• (b) orally administering to the male, following a determination of the male's serum testosterone level at about 6 hours after single dose of the pharmaceutical composition at steady state during the daily dosing regimen, a daily dosing regimen of a pharmaceutical composition once in the morning and once in the evening, with food, comprising about 18 wt % to about 25 wt % testosterone undecanoate and a carrier comprising oleic acid, polyoxyl 40 hydrogenated castor oil, and borage seed oil, that provides within plus/minus 40% of about 450 mg to 480 mg of testosterone undecanoate to said male per day to provide a serum testosterone Cave in said male in the range of from about 300 to 1100 ng/dL and a Cmax of less than 2500 ng/dL.