Preferred oral testosterone undecanoate therapy to achieve testosterone replacement treatment

A method of treating testosterone deficiency in a subject in need thereof, the method comprising:

• a) performing a treatment regimen comprising orally administering to the subject 400 mg of testosterone undecanoate (TU) daily with a meal, wherein the TU is administered in a pharmaceutical composition comprising TU, a non-sterol solubilizing agent effective for solubilization of the TU, and a phytosterol or phytosterol ester;
• b) establishing a first steady state serum concentration of testosterone;
• c) following step (b), providing a first steady state Serum Value of testosterone in the subject that is measured from about 3 hours to about 6 hours after administration of the pharmaceutical composition;
• and
• d) performing a first titration of the testosterone undecanoate, wherein:
• i) if the first Serum Value of testosterone is less than about 460 ng/dL, then orally administering to the subject about 600 mg TU daily to establish a second steady state Serum Value of testosterone that is higher than the first steady state Serum Value of testosterone;
• ii) if the first Serum Value of testosterone is from about 460 ng/dL to about 971 ng/dL, then continuing to orally administer to the subject about 400 mg TU daily to maintain the first steady state Serum Value of testosterone;
• or
• iii) if the first Serum Value of testosterone is greater than about 971 ng/dL, then orally administering to the subject about 200 mg TU daily to establish a second steady state Serum
• Value of testosterone that is lower than the first steady state Serum Value of testosterone;
• wherein the subject:
• is on anti-hypertensive therapy and exhibits an average change in systolic blood pressure of no more than 3.4 mmHg, an average change in diastolic blood pressure of no more than 1.8 mmHg, and/or an average change in heart rate of no more than 1.3 beats per minute;
• and/or
• has diabetes mellitus and exhibits an average change in systolic blood pressure of no more than 3.0 mmHg, an average change in diastolic blood pressure of no more than 1.7 mmHg, and/or an average change in heart rate of no more than 1.9 beats per minute.