High-strength testosterone undecanoate compositions

  • US 9,205,057 B2
  • Filed: 04/20/2015
  • Issued: 12/08/2015
  • Est. Priority Date: 11/30/2010
  • Status: Active Grant
First Claim
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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.

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