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 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. 
     
     
         4 . The method of  claim 3 , wherein said PDE-5 inhibitor is selected from the group consisting of: sildenafil, vardenafil, and tadalafil. 
     
     
         5 . The method of  claim 4 , wherein said PDE-5 inhibitor is tadalafil. 
     
     
         6 . The method of  claim 5 , wherein the effective amount is 2.5 mg or 5 mg. 
     
     
         7 . 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. 
     
     
         8 . The method according to any one of  claims 1 ,  2 , 3  and  7 , wherein an effective amount of fispemifene is in a range of 10 mg to about 1000 mg. 
     
     
         9 . The method according to any one of  claims 1 - 7 , wherein fispemifene is administered as an oral formulation.