Combination preparation for oral contreaception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same

Abstract

The multiphase combination preparation for oral therapy of dysfunctional uterine bleeding and for oral contraception contains a first phase consisting of 2 daily dosage units, each containing 3 mg of estradiol valerate or <3 mg of estradiol; a second phase consisting of a first group of 5 daily dosage units, each consisting of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol, and a second group consisting of 17 daily dosage units, each consisting of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or <2 mg of estradiol; a third phase consisting of 2 daily dosage units, each containing 1 mg of estradiol valerate or <1 mg of estradiol; and another phase consisting of 2 daily dosage units of a pharmaceutically harmless placebos.

1 . A multiphase combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding, said combination preparation containing a first phase consisting of two daily dosage units, each consisting of 3 mg of estradiol valerate or of less than 3 mg of estradiol;
 a second phase consisting of two groups of daily dosage units, a first group of which consisting of 5 daily dosage units, each consisting of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or with less than 2 mg of estradiol, and a second group of which consisting of 17 daily dosage units, each consisting of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or with less than 2 mg of estradiol;   a third phase consisting of two daily dosage units, each consisting of 1 mg of estradiol valerate or of less than 1 mg of estradiol;   
     and another phase consisting of two daily dosage units of a pharmaceutically harmless placebo;
 so that the multiphase combination preparation consists of a total number of 28 daily dosage units. 
 
   
   
       2 . The multiphase combination preparation as defined in  claim 1 , wherein each of said daily dosage units of said first phase consists of 2.25 mg of said estradiol; each of said daily dosage units of said second phase consists of 1.5 mg of said estradiol; and each of said daily dosage units of said third phase consists of 0.75 mg of said estradiol. 
   
   
       3 . The multiphase combination preparation as defined in  claim 1 , wherein each of said daily dosage units of said first phase consists of 3 mg of said estradiol valerate; each of said daily dosage units of said second phase consists of 2 mg of said estradiol valerate; and each of said daily dosage units of said third phase consists of 1 mg of said estradiol valerate. 
   
   
       4 . A method of treating dysfunctional uterine bleeding and of oral contraception, said method comprising the steps of:
 a) providing a multiphase combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding, said combination preparation containing a first phase consisting of two daily dosage units, each consisting of 3 mg of estradiol valerate or of less than 3 mg of estradiol; a second phase consisting of two groups of daily dosage units, a first group of which consisting of 5 daily dosage units, each of which consist of a combination of 2 mg of dienogest with 2 mg of estradiol valerate or less than 2 mg of estradiol, and a second group of which consisting of 17 daily dosage units, each of which consist of a combination of 3 mg of dienogest with 2 mg of estradiol valerate or less than 2 mg of estradiol; a third phase consisting of 2 daily dosage units, each consisting of 1 mg of estradiol valerate or less than 1 mg of estradiol; and another phase of 2 daily dosage units of a pharmaceutically harmless placebo; so that the multiphase combination preparation consists of a total number of 28 daily dosage units; and   b) administering said multiphase combination preparation to a woman in need of treatment for dysfunctional uterine bleeding over at least one treatment cycle.   
   
   
       5 . The method as defined in  claim 4 , wherein said at least one treatment cycle consists of six treatment cycles. 
   
   
       6 . The method as defined in  claim 4 , wherein each of said daily dosage units of said first phase consists of 2.25 mg of said estradiol; each of said daily dosage units of said second phase consists of 1.5 mg of said estradiol; and each of said daily dosage units of said third phase consists of 0.75 mg of said estradiol. 
   
   
       7 . The method as defined in  claim 4 , wherein each of said daily dosage units of said first phase consists of 3 mg of said estradiol valerate; each of said daily dosage units of said second phase consists of 2 mg of said estradiol valerate; and each of said daily dosage units of said third phase consists of 1 mg of said estradiol valerate.