Therapy of estrogen-associated disorders

Abstract

A method for the treatment, prophylaxis, amelioration or prevention of disorders associated with abnormally high activity of steroidal estrogens, which includes administering to a human subject a composition comprising an isoflavone-containing extract of clover or chick peas, said extract comprising primarily biochanin, or a ratio of biochanin to one or more of the isoflavones from the group formononetin, daidzein and genistein in the range of from about 2:1 to about 5:1, optionally in association with one or more pharmaceutically acceptable carriers, excipients, auxiliaries and/or diluents is described. Also described are compositions and uses comprising the isoflavone containing extracts.

1 . A method for the treatment, prophylaxis, amelioration or prevention of disorders associated with an abnormally high activity of steroidal estrogen, which includes administering to a human subject a composition comprising an isoflavone containing extract of clover or chick pea, or an isoflavone extract of clover or chick pea comprising primarily biochanin or biochanin and any one or more of the isoflavones from the group formononetin, daidzein and genistein at a ratio from about 2:1 to about 5:1, optionally in association with one or more pharmaceutically acceptable carriers, excipients, auxiliaries and/or diluents.  
     
     
         2 . A method according to  claim 1  wherein the disorder is selected from uterine fibroids, polycystic ovarian disease, ovarian cysts, cyclical acne, mastalgia, endometriosis and endometrial hyperplasia.  
     
     
         3 . A method according to  claim 1  wherein the isoflavone containing extract primarily comprising biochanin comprises at least 65% biochanin by weight, the remainder comprising essentially formononetin and/or daidzein and/or genistein.  
     
     
         4 . A method according to  claim 3  comprising  70  to 100% biochanin.  
     
     
         5 . A method according to  claim 1  wherein the ratio of biochanin to one or more of the ioflavones from the group formononetin, daidzein and genistein is from about 7:3 to about 5:1.  
     
     
         6 . A method according to  claim 1  wherein the extract of clover or chick peas is a water/water-miscible organic solvent extract.  
     
     
         7 . A method according to  claim 1  wherein the clover is red clover.  
     
     
         8 . A method according to  claim 1  wherein the isoflavone is in a glycoside, agylcone, acetyl or malonyl form.  
     
     
         9 . A composition comprising an isoflavone extract of clover or chick pea, said extract comprising biochanin and one or more of the isoflavones from the group formononetin, daidzein and genistein at a ratio from about 2:1 to about 5:1, optionally in association with one or more pharmaceutically acceptable carriers, excipients, auxiliaries, and/or diluents.  
     
     
         10 . A composition according to  claim 9  wherein the ratio of biochanin to one or more of the isoflavones from the group formononetin, daidzein and genistein is from about 7:3 to about 5:1.  
     
     
         11 . A composition according to  claim 9  wherein the extract of clover or chick peas is a water/water-miscible organic solvent extract.  
     
     
         12 . A composition according to claimn  9  wherein the isoflavone is in a glycoside, agylcone, acetyl or malonyl form.  
     
     
         13 . Use of a composition comprising an isoflavone extract of clover or chick pea, said extract comprising primarily biochanin, or a ratio of biochanin to one or more of the isoflavones from the group formononetin, daidzein and genistein in the range of from about 2:1 to about 5:1, optionally in association with one or more pharmaceutically acceptable carriers, excipients, auxiliaries, and/or diluents for the manufacture of a medicament for the treatment, prophylaxis, amelioration or prevention of an disorders associated with an abnormally high activity of steroidal estrogen.  
     
     
         14 . A use according to  claim 13  wherein the disorder is selected from uterine fibroids, polycystic ovarian disease, ovarian cysts, cyclical acne, mastalgia, endometriosis and endometrial hyperplasia.  
     
     
         15 . A use according to  claim 13  wherein the isoflavone containing extract primarily comprising biochanin comprises at least 65% biochanin by weight, the remainder comprising isoflavones from the group formononetin, daidzein and genistein.  
     
     
         16 . A use according to  claim 14  comprising 70 to 100% biochanin.  
     
     
         17 . A use according to  claim 13  wherein the ratio of biochanin to one or more of the isoflavones from the group formononetin, daidzein and genistein is in the range of from about 7:3 to about 5:1.  
     
     
         18 . A use according to  claim 13  wherein the isoflavone is in a glycoside, agylcone, acetyl or malonyl form.