Selective progesterone receptor modulator (sprm) regimen

Abstract

The invention is directed to a pharmaceutical composition comprising a progesterone receptor antagonist namely (11β, 17β)-17-Hydroxy-11-[4-(methylsulphonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one for the treatment and/or prophylaxis of Uterine Fibroids (myomas, uterine leiomyoma) that is administered to a patient diagnosed with Uterine Fibroids following a specific regimen. Additionally, the invention is directed to a method for treating Uterine Fibroids (myomas, uterine leiomyoma) and/or for reducing Uterine Fibroids (myomas, uterine leiomyoma) size and symptoms related to Uterine Fibroids following a specific regimen as well as treatment of Heavy Menstrual Bleeding (HMB).

1 . A method for treating Heavy Menstrual Bleeding (HMB) by administering to a patient a pharmaceutical composition comprising (11β,17β)-17-Hydroxy-11-[4-(methylsulphonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one (Compound 1) of formula 
       
         
           
           
               
               
           
         
         or salts, solvates or solvates of the salts, including all crystal modifications thereof, comprising the steps of: 
         administering the pharmaceutical composition daily during a period of four (4) weeks to one (1) year, and 
         discontinuing the administration until one (1) or two (2) bleeding episodes occur. 
       
     
     
         2 . The method of  claim 1  wherein the administering step and the discontinuing step are repeated at least one (1) time. 
     
     
         3 . The method of  claim 1  wherein the period is from twelve (12) weeks up to twenty-four (24) weeks. 
     
     
         4 . The method of  claim 1  wherein the period is selected from the group consisting of twelve (12) weeks; sixteen (16) weeks; twenty (20) weeks; and twenty-four (24) weeks. 
     
     
         5 . The method of  claim 4 , wherein the period is twelve (12) weeks. 
     
     
         6 . The method of  claim 5 , wherein the administration is discontinued until one (1) bleeding period occurs. 
     
     
         7 . The method of  claim 6 , wherein the bleeding period is followed by administration for twelve (12) weeks. 
     
     
         8 . The method of  claim 4 , wherein the period is twenty-four (24) weeks. 
     
     
         9 . The method of  claim 8 , wherein the administration is discontinued until two (2) bleeding periods occur. 
     
     
         10 . The method of  claim 9 , wherein the second bleeding period is followed by administration for twenty-four (24) weeks. 
     
     
         11 . The method of  claim 1 , wherein amenorrhea occurs after about three (3) weeks. 
     
     
         12 . The method of  claim 5 , wherein amenorrhea occurs after about three (3) weeks. 
     
     
         13 . The method of  claim 8 , wherein amenorrhea occurs after about three (3) weeks. 
     
     
         14 . The method of  claim 1 , wherein Compound 1 is administered at a dose of 1 mg to 5 mg. 
     
     
         15 . The method of  claim 5 , wherein Compound 1 is administered at a dose of 1 mg to 5 mg. 
     
     
         16 . The method of  claim 8 , wherein Compound 1 is administered at a dose of 1 mg to 5 mg. 
     
     
         17 . The method of  claim 1 , wherein Compound 1 is administered at a dose of about 2 mg. 
     
     
         18 . The method of  claim 5 , wherein Compound 1 is administered at a dose of about 2 mg. 
     
     
         19 . The method of  claim 8 , wherein Compound 1 is administered at a dose of about 2 mg. 
     
     
         20 . The method of  claim 4 , wherein the period is sixteen (16) weeks.