ORAL TESTOSTERONE UNDECANOATE THERAPY
The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.
1 . A method of restoring serum testosterone levels to a normal eugonadal range in a male having a condition associated with a deficiency or absence of endogenous testosterone, comprising orally administering a pharmaceutical composition comprising a therapeutically effective amount of testosterone undecanoate (TU) in a fixed dose administration regimen with food.
2 . The method of claim 1 , wherein the composition further comprises an additive.
3 . The method of claim 1 , wherein the fixed dose administration regimen provides a total daily dose of TU of from 420-500 mg.
4 . The method of claim 1 , wherein the fixed dose administration regimen comprises administering said composition twice daily.
5 . The method of claim 1 , wherein said composition is in the form of a hard or soft capsule.
6 . The method of claim 1 , wherein a unit dosage form of the composition comprises about 112.5 mg TU, about 75 mg TU, about 158 mg TU, about 237 mg TU, or about 225 mg TU.
7 . The method of claim 1 , further comprising measuring a therapy discontinuation criterion that indicates an advised discontinuation of therapy where serum testosterone (T) levels are consistently >2500 ng/dl.
8 . A method of restoring daily average serum testosterone (C avg ) to a normal eugonadal range in at least 75% of males in a population having a condition associated with a deficiency or absence of endogenous testosterone, comprising oral administration of an oral dosage form comprising a therapeutically effective amount of testosterone undecanoate (TU) in a fixed dose administration regimen with food.
9 . The method of claim 8 , wherein the oral dosage form further comprises an additive.
10 . The method of claim 8 , wherein the fixed dose administration regimen provides a total daily TU dose of from 420-500 mg.
11 . The method of claim 8 , wherein the fixed dose administration regimen comprises administering said oral dosage form twice daily.
12 . The method of claim 8 , wherein said dosage form is in the form of a hard or soft capsule.
13 . The method of claim 8 , wherein the therapeutically effective amount is provided by an oral dosage form having about 75 mg TU, about 112.5 mg TU, about 150 mg TU, about 158 mg TU, about 237 mg TU or about 225 mg TU.
14 . The method of claim 8 , further comprising measuring a therapy discontinuation criterion that indicates an advised discontinuation of therapy where serum T levels are consistently >2500 ng/dl.
15 . A method of treating a condition associated with a deficiency or absence of endogenous testosterone in a male patient, comprising: orally administering a fixed dose of 200-250 mg of testosterone undecanoate (TU) twice daily in a fixed dose dosing regimen with food.
16 . The method of claim 15 , wherein the fixed dose provides from 215-230 mg testosterone undecanoate per dose.
17 . The method of claim 15 , wherein the fixed dose provides from 420-500 mg testosterone undecanoate per day.
18 . The method of claim 15 , wherein the fixed dose provides from 230-240 mg testosterone undecanoate per dose.
19 . The method of claim 15 , wherein the fixed dose provides from 235-239 mg testosterone undecanoate per dose.
20 . The method of claim 15 , wherein the fixed dose provides from 223-227 mg testosterone undecanoate per dose.
21 . The method of claim 15 , wherein the fixed dose provides from 465-485 mg testosterone undecanoate per day.
22 . The method of claim 15 , wherein the fixed dose provides from 445-455 mg testosterone undecanoate per day.
23 . The method of claim 15 , further comprising determining a serum testosterone level of said male patient after initiation of administration of TU.
24 . The method of claim 15 , further comprising determining a serum testosterone level of said male after initiation of TU administration, wherein unacceptably high serum testosterone levels after reaching a steady state indicates an advised discontinuation of therapy.
25 . The method of claim 15 , further comprising determining a serum testosterone level of said male after initiation of TU administration, wherein unacceptably low serum testosterone levels after reaching a steady state indicates an advised discontinuation of therapy.
26 . The method of claim 15 , wherein the fixed dose provides from 425-500 mg testosterone undecanoate per day.
27 . The method of claim 15 , wherein the fixed dose provides from 435-495 mg testosterone undecanoate per day.
28 . The method of claim 15 , wherein the fixed dose provides from 440-490 mg testosterone undecanoate per day.
29 . The method of claim 15 , wherein the fixed dose provides from 440-480 mg testosterone undecanoate per day.
30 . The method of claim 15 , wherein the fixed dose provides from 448-452 mg testosterone undecanoate per day.