METHODS OF TREATING TESTOSTERONE DEFICIENCY
Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone esters are provided. The methods are designed to provide optimum serum testosterone levels over an extended period.
1 .- 24 . (canceled)
25 . A method of treating chronic testosterone deficiency in a subject in need thereof comprising the steps of:
a) administering daily to a subject in need thereof about 475 mg of an oral pharmaceutical composition comprising:
15-20 percent by weight of solubilized testosterone undecanoate;
5-20 percent by weight hydrogenated castor oil ethoxylate;
30-70 percent by weight of oleic acid; and
10-15 percent by weight of digestible oil;
b) measuring the serum testosterone concentration in the subject three to five hours following the daily administration of the oral pharmaceutical composition; and
c) increasing the dose of testosterone ester administered in step a. when the measured serum testosterone concentration in the subject is less than about 250 ng/dL, decreasing each dose of testosterone ester administered in step a. when the measured serum testosterone concentration in the subject is greater than about 700 ng/dL, and maintaining each dose of testosterone ester administered in step a. when the measured serum testosterone concentration in the subject is between about 250 ng/dL and about 700 ng/dL;
wherein steps a)-c) are repeated until the serum testosterone concentration in the subject is between about 250 and about 700 ng/dL;
wherein the serum testosterone concentration is measured after seven days of daily treatment with the oral pharmaceutical composition; and
wherein the oral pharmaceutical composition is administered twice daily.
26 . The method of claim 25 , wherein, once steady-state is achieved, the serum testosterone response does not decline over time.
27 . The method of claim 25 , wherein said oral pharmaceutical composition is administered in one or more capsules.