Back to results
US 2017/0246184 A1Published application
Methods of treating testosterone deficiency
AssigneeClarus Therapeutics, Inc.
InventorsRobert E. DUDLEY, Panayiotis P. CONSTANTINIDES, James A. LONGSTRETH
Life of this patent
Estimating the term…
Abstract
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.
Claims5
-24. (canceled)
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.
9 more elements
Dependencies are inferred from the claim text.