Oral testosterone tridecanoate therapy
OwnerNachiappan Chidambaram, Satish Kumar Nachaegari +2inventors
InventorsNachiappan Chidambaram, Satish Kumar Nachaegari, Mahesh V. Patel, Kilyoung Kim
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Abstract
The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.
Claims42
A method of restoring serum testosterone levels to a normal eugonadal range in a male having a condition associated with a deficiency or absence of endogenous testosterone, comprising orally administering a pharmaceutical composition comprising a therapeutically effective amount of testosterone tridecanoate (T13) in a fixed dose administration regimen with food.
A method of restoring daily average serum testosterone (Cavg) to a normal eugonadal range in at least 75% of males in a population having a condition associated with a deficiency or absence of endogenous testosterone, comprising oral administration of an oral dosage form comprising a therapeutically effective amount of testosterone tridecanoate (T13) in a fixed dose administration regimen with food.
A method of treating a condition associated with a deficiency or absence of endogenous testosterone in a male patient, comprising:
- orally administering a fixed dose of 375-575 mg of testosterone tridecanoate (T13) twice daily or 750-1150 mg once daily in a fixed dose dosing regimen with food.
Dependencies are inferred from the claim text.