Therapeutic Regimens

Abstract

This invention relates to clinically useful therapeutic regimens comprising the administration of (R)-6-(2-(ethyl(4-(2-(ethylamino)ethyl)benzyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol.

1 . A unit dosage form comprising 10 mg of the compound of formula I as its dihydrochloride salt 
       
         
           
           
               
               
           
         
       
     
     
         2 . The unit dosage form according to  claim 1 , further comprising one or more pharmaceutically acceptable excipients. 
     
     
         3 . The unit dosage form according to  claim 2 , wherein the unit dosage form is a tablet or capsule suitable for oral administration. 
     
     
         4 . The unit dosage form according to  claim 3 , wherein following oral administration the unit dosage form, is more than 50% dissolved in the stomach prior to being released into the small intestines. 
     
     
         5 . The unit dosage form according to  claim 4 , wherein the unit dosage form is not coated with an acid resistant coating. 
     
     
         6 . A method of treating vasomotor disturbances in a peri-menopausal or postmenopausal woman in need thereof comprising administering to the woman the unit dosage form of  claim 1 . 
     
     
         7 - 8 . (canceled) 
     
     
         9 . The method according to  claim 6 , wherein the unit dosage form is more than 50% dissolved in the stomach prior to being released into the small intestines. 
     
     
         10 . The method according to  claim 9 , wherein the unit dosage form is not coated with an acid resistant coating. 
     
     
         11 . A method of treating vasomotor disturbances in a peri-menopausal or postmenopausal woman in need thereof comprising administering to the woman a compound of formula I or a salt thereof 
       
         
           
           
               
               
           
         
       
       wherein the administration results in a steady state C max  of from 0.40 ng/mL to 1.43 ng/mL. 
     
     
         12 . The method of  claim 11 , wherein a steady state trough level of the compound of formula I ranging from 0.11 ng/mL to 0.79 ng/mL or ranging from 0.12 ng/mL to 0.86 ng/mL is achieved. 
     
     
         13 . The method of  claim 11 , wherein the compound of formula I is in the form of a dihydrochloride salt. 
     
     
         14 . (canceled) 
     
     
         15 . The method of  claim 13 , wherein the compound is orally administered once daily in a unit dosage form. 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 15 , wherein the unit dosage form is a capsule or tablet and is more than 50% dissolved in the stomach prior to being released into the small intestines. 
     
     
         18 . The method according to  claim 17 , wherein the unit dosage form is not coated with an acid resistant coating. 
     
     
         19 . A method of treating vasomotor disturbances in a peri-menopausal or postmenopausal woman in need thereof comprising administering to the woman a compound of formula I or a salt thereof 
       
         
           
           
               
               
           
         
       
       wherein the administration results in a steady state C max  of from 0.22 ng/mL to 1.61 ng/mL 
     
     
         20 . The method of  claim 19 , wherein the compound of formula 1 is in its dihydrochloride salt form. 
     
     
         21 . The method of  claim 19 , wherein a steady state trough level of the compound of formula I ranging from 0.11 ng/mL to 0.79 ng/mL or ranging from 0.12 ng/mL to 0.86 ng/mL is achieved. 
     
     
         22 . The method of  claim 19 , wherein the compound of formula I is in the form of a dihydrochloride salt. 
     
     
         23 . (canceled) 
     
     
         24 . The method of  claim 22 , wherein the compound is orally administered once daily in a unit dosage form. 
     
     
         25 . (canceled) 
     
     
         26 . The method of  claim 24 , wherein the unit dosage form is a capsule or tablet and is more than 50% dissolved in the stomach prior to being released into the small intestines. 
     
     
         27 . The method according to  claim 26 , wherein the unit dosage form is not coated with an acid resistant coating.