Methods for the treatment of erectile dysfunction using fispemifene

Abstract

A method of treatment of erectile dysfunction (ED) comprises the step of administering fispemifene to a subject in need thereof in an amount effective to raise the subject's testosterone level. Fispemifene may be used in combination with a PDE-5 inhibitor in individuals who have failed to respond sufficiently to conventional ED treatment. Methods are also disclosed of treating ED by administering clomifene, enclomifene, ospemifene, toremifene and mixtures thereof in combination with a PDE-5 inhibitor.

1 . A method of treating erectile dysfunction, comprising the step of administering an effective amount of fispemifene to a subject in need thereof. 
   
   
       2 . A method of treating erectile dysfunction, comprising the step of determining that the individual has low serum total testosterone, in a range of less than about 400 ng/dL, and administering fispemifene in an amount effective to increase serum testosterone. 
   
   
       3 . A method of treating erectile dysfunction comprising the steps of: (1) administering to an individual in need thereof an effective amount of a PDE-5 inhibitor in combination with, (2) administering to the individual an amount of fispemifene, clomifene, enclomifene, ospemifene or toremifene effective to increase testosterone in said individual. 
   
   
       4 . A method of treating erectile dysfunction in an individual insufficiently responsive to treatment with a PDE-5 inhibitor, comprising administering fispemifene to said individual in an amount effective to treat the erectile dysfunction. 
   
   
       5 . The method of  claim 4 , wherein said PDE-5 inhibitor is selected from the group consisting of: sildenafil, vardenafil, and tadalafil. 
   
   
       6 . The method of  claim 6 , wherein said PDE-5 inhibitor is tadalafil. 
   
   
       7 . The method of  claim 6 , wherein the effective amount is 2.5 mg or 5 mg. 
   
   
       8 . A method of treating erectile dysfunction in an individual insufficiently responsive to treatment with a PDE-5 inhibitor, comprising (1) a step of administering a PDE-5 inhibitor to a subject in need thereof and observing a failure of the subject to respond; and (2) administering fispemifene, clomifene, enclomifene, ospemifene or toremifene to said individual in combination with a PDE-5 inhibitor, in a fixed daily dose effective to treat the erectile dysfunction. 
   
   
       9 . A method of treating erectile dysfunction in an individual insufficiently responsive to treatment with a PDE-5 inhibitor, comprising the steps of: (1) administering a PDE-5 inhibitor to a subject in need thereof and observing a failure of the subject to respond; (2) measuring the serum testosterone level of the subject to determine that the level is less than 400 ng/dl; and (3) administering a fixed daily dose of fispemifene, clomifene, enclomifene, ospemifene or toremifene in combination with a PDE-5 inhibitor to said individual effective to treat the erectile dysfunction. 
   
   
       10 . The method according to  claim 9 , wherein the fixed daily dose is an oral dosage form of fispemifene and an oral dosage form of a PDE-5 inhibitor. 
   
   
       11 . A method of treating erectile dysfunction in an individual having low testosterone and who is suffering from chronic obstructive pulmonary disease, HIV infection, or metabolic syndrome, comprising administering an effective amount of fispemifene to said individual. 
   
   
       12 . The method according to any one of the preceding claims, wherein an effective amount of fispemifene is in a range of 10 mg to about 1000 mg. 
   
   
       13 . The method according to any one of the preceding claims, wherein fispemifene is administered as an oral formulation. 
   
   
       14 . A single unit dosage form comprising:
 an effective amount of fispemifene; and   an effective amount of a PDE-5 inhibitor; and a pharmaceutically acceptable carrier or diluent.   
   
   
       15 . The unit dosage form of  claim 14 , wherein said PDE-5 inhibitor is selected from the group consisting of: sildenafil, vardenafil and tadalafil. 
   
   
       16 . The unit dosage form of  claim 14 , wherein said PDE-5 inhibitor is tadalafil. 
   
   
       17 . The unit dosage form of  claim 16 , wherein the effective amount is 2.5 mg or 5 mg.