Oral testosterone therapy
OwnerNachiappan Chidambaram, Satish K. Nachaegari +2inventors
InventorsNachiappan Chidambaram, Satish K. Nachaegari, Mahesh V. Patel, Kilyoung Kim
Life of this patent
Estimating the term…
Abstract
Disclosed are methods and compositions for testosterone replacement therapy, especially for use in administration to hypogonadal males. The methods and compositions employ an untitrated dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester, such as a non-undecanoate testosterone ester, while avoiding unacceptably high testosterone levels.
Claims30
A method of treating a subject having a condition associated with at least one of fatigue, a reduction in muscle size, and a reduction in muscle strength, said method comprising orally administering a pharmaceutical composition comprising a therapeutically effective amount of a non-undecanoate testosterone ester in an untitrated dose administration regimen with food.
A method of treatment comprising orally administering with food at least one of:
- an untitrated dose of about 100-500 mg of a non-undecanoate testosterone ester in an untitrated dose dosing regimen, and
- a total daily dose of at least about 500 mg of a non-undecanoate testosterone ester in an untitrated dose dosing regimen.
A pharmaceutical composition comprising (i) a therapeutically effective amount of a non-undecanoate testosterone ester;
- (ii) at least one pharmaceutically acceptable carrier;
- and (iii) at least one additive, wherein said non-undecanoate testosterone ester comprises about 15%-45% w/w of said composition, wherein administration of said composition to a subject having a condition associated with at least one of fatigue, a reduction in muscle size, and a reduction in muscle strength, results in improving or preventing further worsening of said at least one of fatigue, said reduction in muscle size and said reduction in muscle strength.
Dependencies are inferred from the claim text.