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US 2020/0046732 A1Published application
Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
AssigneeClarus Therapeutics, Inc.
InventorsRobert E. DUDLEY, Panayiotis P. CONSTANTINIDES
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Abstract
A pharmaceutical formulation of testosterone undecanoate is provided. Methods of treating a testosterone deficiency or its symptoms with the inventive formulations are also provided.
Claims31
-26. (canceled)
A method for treating a hypogonadal male comprising
- orally administering to the male, a composition comprising a liquid or semi-solid formulation encased within a capsule, the formulation comprising
- 15-25 percent by weight of testosterone undecanoate, 12-18 percent by weight of hydrophilic surfactant, and 50-65 percent by weight of lipophilic surfactant,
- wherein the total TU administered per day ranges from about 316 mg TU to about 948 mg TU, and
- wherein the composition, when orally administered to the male provides, at steady state, an average serum testosterone concentration Cave of from about 300 to about 1100 ng/dl.
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Dependencies are inferred from the claim text.