Fixed dose oral testosterone undecanoate compositions and use thereof
OwnerMahesh V. Patel, Nachiappan Chidambaram +1inventors
InventorsMahesh V. Patel, Nachiappan Chidambaram, Kilyoung Kim
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Abstract
Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.
Claims36
A Testosterone Undecanoate (TU) pharmaceutical composition for restoring an effective amount of T concentration in a subject in response to a predetermined dose oral administration therapy regimen thereof, wherein said composition includes a continuation criteria comprising a single serum T concentration level measured at a predetermined number of weeks after initiation of said regimen and at a predetermined number of hours after administering a dose of said regimen, wherein if said single serum T measured concentration level is within a range of about 300 ng/dL to about 1080 ng/dL, said regimen is continued, and wherein if said single serum T concentration level is not within a range of about 300 ng/dL to about 1080 ng/dL, said regimen is discontinued.
A Testosterone Undecanoate (TU) pharmaceutical composition for restoring an effective amount of T concentration in a subject in response to a predetermined dose oral administration therapy regimen thereof, wherein said composition includes a continuation criteria comprising the monitoring of a single serum T concentration level measured at a predetermined number of weeks after initiating said regimen and at a predetermined number of hours after administering a morning dose of said regimen, wherein if said measured serum T concentration level is within the range of about 300 ng/dL to about 1080 ng/dL, said regiment is continued, and wherein if said measured serum T concentration level is less than about 300 ng/dL, said regiment is discontinued, and wherein if said measured serum T concentration level is greater than about 1080 ng/dL, said regiment is discontinued.
A method of continuing or discontinuing a predetermined dose oral administration regimen of a TU pharmaceutical composition comprising:
- initiating said regimen to a subject having a testosterone concentration below 300 ng/dL;
- measuring a steady state single serum T concentration level at a predetermined number of hours after administration of a dose of said regimen a predetermined number of weeks after initiation of said regimen;
- and
- continuing said regimen if said measurement is within a range of about 300 ng/dL to about 1,080 ng/dL and discontinuing said regimen if said measurement is not within a range of about 300 ng/dL to about 1,080 ng/dL.
A method of continuing or discontinuing a predetermined dose oral administration regimen of a TU pharmaceutical composition comprising:
- initiating said regimen to a subject having a testosterone concentration below 300 ng/dL;
- measuring a steady state single serum T concentration level at a predetermined number of hours after administration of a morning dose of said regimen a predetermined number of weeks after initiation of said regimen;
- and
- continuing said regimen if said measurement is within a range of about 300 ng/dL to about 1,080 ng/dL.
Dependencies are inferred from the claim text.