Method for treating benign prostatic hyperplasia

Abstract

The use of 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol, or a pharmaceutically acceptable salt or ester thereof, for the manufacture of a medicament for the prevention and/or treatment of benign prostatic hyperplasia (BPH) and associated symptoms.

1 - 6 . (canceled) 
     
     
         7 . A packaged formulation including a pharmaceutical composition comprising 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol, or a pharmaceutically acceptable salt or ester thereof, and a pharmaceutically acceptable carrier packaged with instructions for use in the prevention and/or treatment of benign prostatic hyperplasia. 
     
     
         8 - 9 . (canceled) 
     
     
         10 . A package formulation according to  claim 7  wherein the composition comprising 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol, or pharmaceutically acceptable salt or ester thereof, is provided in unit dose form. 
     
     
         11 - 12 . (canceled) 
     
     
         13 . A package formulation according to  claim 10  wherein the unit dose of 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol is 50 to 150 μg. 
     
     
         14 - 17 . (canceled) 
     
     
         18 . A pharmaceutical formulation comprising 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol dissolved in fractionated coco oil together with one or more preservatives. 
     
     
         19 . A pharmaceutical formulation according to  claim 18  wherein the fractionated coco oil is Miglyol 812. 
     
     
         20 . A pharmaceutical formulation according to  claim 18  wherein the preservatives are selected from butylated hydroxytoluene, butylated hydroxyanisole and mixtures thereof. 
     
     
         21 . A packaged formulation according to  claim 7  where the composition is presented as a capsule. 
     
     
         22 . A formulation according to  claim 18  which is presented as a capsule. 
     
     
         23 - 26 . (canceled) 
     
     
         27 . A packaged formulation including a pharmaceutical composition comprising 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol, or a pharmaceutically acceptable salt or ester thereof, and a pharmaceutically acceptable carrier packaged with instructions for use in the prevention and/or treatment of benign prostatic hyperplasia together with concurrent prevention and/or treatment of bladder dysfunction. 
     
     
         28 . A package formulation according to  claim 27  wherein the composition comprising 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol, or pharmaceutically acceptable salt or ester thereof, is provided in unit dose form. 
     
     
         29 . A package formulation according to  claim 28  wherein the unit dose of 1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol is 50 to 150 μg. 
     
     
         30 . A packaged formulation according to  claim 27  where the composition is presented as a capsule.