Progesterone Receptor Modulators for Use in the Therapy of Uterine Fibroids

Abstract

The present invention relates to a long-term therapy including repeated treatment courses of ulipristal acetate or any metabolite thereof for treating uterine fibroids. The present invention also relates to a combined therapy applying ulipristal acetate with a progestin in order to improve the currently used treatment for uterine fibroids.

1 - 10 . (canceled) 
     
     
         11 . A method of treating uterine fibroids in a patient in need thereof, comprising administering to the patient ulipristal acetate or a metabolite thereof in a therapeutically effective amount in sequential treatment periods, wherein each treatment period lasts 2-6 months and each treatment period is followed by a drug-free period. 
     
     
         12 . The method of  claim 11  wherein each treatment period lasts 2-4 months. 
     
     
         13 . The method of  claim 11 , wherein each treatment period lasts 12 weeks. 
     
     
         14 . The method of  claim 11 , wherein the drug-free period comprises at least one menstruation cycle. 
     
     
         15 . The method of  claim 11 , wherein the drug-free period comprises at least two menstruation cycles. 
     
     
         16 . The method of  claim 11 , wherein the drug-free period comprises at least three menstruation cycles. 
     
     
         17 . The method of  claim 11 , wherein the drug-free period is not more than 6 months. 
     
     
         18 . The method of  claim 11 , wherein the ulipristal acetate or a metabolite thereof is administered daily. 
     
     
         19 . The method of  claim 18 , wherein the daily amount is 5-15 mg ulipristal acetate or a metabolite thereof. 
     
     
         20 . The method of  claim 19 , wherein the daily amount is 10 mg ulipristal acetate. 
     
     
         21 - 50 . (canceled)