Patent ID: 9205057
Filing Date: 2015-12-08
Classification: A61K,A61P,G01N

Abstract:
1. 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 said male a daily dosing regimen of a pharmaceutical composition comprising about 14 weight % (wt %) to about 35 wt % testosterone undecanoate and a carrier, that provides from about 360 mg to about 480 mg of testosterone undecanoate to said male per day; (b) Determining the serum level of testosterone of said male during the daily dosing regimen at from 1-8 hours after single dose administration of said pharmaceutical composition at steady state; and (c) Orally administering a maintenance daily dosing regimen of a pharmaceutical composition comprising about 14 wt % to about 35 wt % testosterone undecanoate and a carrier, that provides within plus or minus 40% of from about 360 mg to about 480 mg of testosterone undecanoate to said male based on the serum testosterone level determined in step (b), to provide a serum testosterone Cave in said male in the range of from about 300-1100 ng/dL.