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US 2024/0180927 A1Published application
Methods of Treating Testosterone Deficiency
AssigneeTolmar, 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.
Claims18
1-30. (canceled)
A method of treating one or more conditions associated with a deficiency or absence of endogenous testosterone in a subject, comprising:
- administering a defined dose of testosterone undecanoate to the subject in an oral pharmaceutical composition twice daily, once in the morning and once in the evening, wherein the defined dose is 237 mg of testosterone undecanoate;
- measuring serum testosterone concentration in the subject at steady state after at least seven days of daily administration of the defined dose and 6 hours after administration of a morning dose;
- and
- either:
- increasing the defined dose of testosterone undecanoate to 316 mg when the measured serum testosterone concentration is less than about 425 ng/dL, maintaining the defined dose of testosterone undecanoate when the measured serum testosterone concentration is between about 425 ng/dl and about 970 ng/dL;
- or
- decreasing the defined dose of testosterone undecanoate to 198 mg when the measured serum testosterone concentration is greater than about 970 ng/dL;
- wherein the oral pharmaceutical composition comprises the testosterone undecanoate solubilized in a carrier comprising at least one lipophilic surfactant and at least one hydrophilic surfactant.
5 more elements
Dependencies are inferred from the claim text.