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 the subject a dose of an oral pharmaceutical composition comprising:
i. 15 percent by weight of solubilized testosterone undecanoate;
ii. 16 percent by weight of polyoxyethylene (40) hydrogenated castor oil;
iii. 63 percent by weight of glyceryl monolinoleate; and
iv. 6 percent by weight of polyethylene glycol 8000;
b. measuring the serum testosterone concentration in the subject, wherein said measurement of serum testosterone concentration is made from two to six hours after one of a series of repeated doses of said oral pharmaceutical composition comprising a testosterone ester solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant; 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; and
wherein the serum testosterone concentration is measured after seven days of daily treatment with the oral pharmaceutical composition.
26 . The method of claim 25 , wherein the oral pharmaceutical composition is administered twice daily.
27 . The method of claim 25 , wherein the serum testosterone concentration is measured three to five hours after administering the oral pharmaceutical composition.
28 . The method of claim 25 , wherein, once steady-state is achieved, the serum testosterone response does not decline over time.