Methods of treating testosterone deficiency
AssigneeClarus Therapeutics, Inc.
InventorsRobert E. DUDLEY, Theodore DANOFF, James A. LONGSTRETH
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Abstract
Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone undecanoate are provided.
Claims30
A method of treating conditions associated with a deficiency or absence of endogenous testosterone in a subject in need thereof comprising the steps of:
- administering to the subject a defined dose of an oral pharmaceutical composition comprising testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant, wherein the defined dose is 198 mg administered twice daily;
- collecting a blood sample from the subject;
- measuring the serum testosterone concentration in the subject;
- and
- increasing the dose of testosterone undecanoate to 237 mg, administered twice daily, when the measured serum testosterone concentration in the subject is less than about 425 ng/dL,
- decreasing the dose of testosterone undecanoate to 158 mg, administered twice daily, when the measured serum testosterone concentration in the subject is greater than about 970 ng/dL, or
- maintaining the dose of testosterone undecanoate when the measured serum testosterone concentration in the subject is between about 425 ng/dL and about 970 ng/dL.
A method of treating conditions associated with a deficiency or absence of endogenous testosterone in a subject in need thereof comprising the steps of:
- administering to the subject a defined dose of an oral pharmaceutical composition comprising testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant, wherein the defined dose is 396 mg administered twice daily;
- collecting a blood sample from the subject;
- measuring the serum testosterone concentration in the subject;
- and
- decreasing the dose of testosterone undecanoate to 316 mg, administered twice daily, when the measured serum testosterone concentration in the subject is greater than about 970 ng/dL, or
- maintaining the dose of testosterone undecanoate when the measured serum testosterone concentration in the subject is between about 425 ng/dL and about 970 ng/dL.
A method of treating conditions associated with a deficiency or absence of endogenous testosterone in a subject in need thereof comprising the steps of:
- administering to the subject a defined dose of an oral pharmaceutical composition comprising testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant, wherein the defined dose is 158 mg administered twice daily;
- collecting a blood sample from the subject;
- measuring the serum testosterone concentration in the subject;
- and
- increasing the dose of testosterone undecanoate to 198 mg, administered twice daily, when the measured serum testosterone concentration in the subject is less than about 425 ng/dL, and
- treatment is discontinued when the subject's measured serum testosterone concentration in the subject is greater than about 970 ng/dL.
Dependencies are inferred from the claim text.