Estrogenic substances combined with cruciferous indole compounds

Abstract

Provided herein are medicinal compositions of matter that comprise an estrogenic medication component and a cruciferous indole component (indole 3-carbinol, diindolylmethane, or any derivative thereof). Through use of the compositions of the invention a heretofore unobserved synergy is observed in the treatment of perimenopause, menopause or any other cause of ovarian failure. The invention also provides procedures for administering the composition to a patient who is afflicted with perimenopause, menopause or any other cause of ovarian failure.

I claim:  
     
         1 ) A method of providing estrogen replacement therapy to a patient, the method comprising: 
 administration of a therapeutically-effective amount of a estrogenic substance and    a therapeutically-effective amount of a cruciferous indole compound selected    from the group consisting of: indole 3-carbinol; and diindolylmethane, and derivatives thereof.    
     
     
         2 ) A method according to  claim 1  wherein the estrogenic substance is administered to alleviate symptoms of estrogen deficiency, and the cruciferous indole compound is administered to increase 2-hydroxyestrogen metabolites and to decrease 16-hydroxyestrogen metabolites in said patient.  
     
     
         3 ) A method according to  claim 1  wherein the administration is selected from the group consisting of: oral and parenteral administration.  
     
     
         4 ) A method according to  claim 1 , wherein the estrogen replacement therapy medication is selected from a group consisting of: estrogen; conjugated estrogens; dienestrol; estrone; esterified estrogens; estradiol; estriol; and estropipate; ethinyl estradiol; or any estrogenic derivative of the foregoing.  
     
     
         5 ) A method according to  claim 1 , wherein the estrogenic substance is compounded into a single oral unit with the cruciferous indole compound.  
     
     
         6 ) A method according to  claim 5 , wherein the single oral unit is a tablet.  
     
     
         7 ) A method according to  claim 5 , wherein the single oral unit is a capsule.  
     
     
         8 ) A method according to  claim 1 , wherein the estrogenic substance and the cruciferous indole compound are dissolved or suspended in oil to provide an oil suspension.  
     
     
         9 ) A method according to  claim 8  wherein said oil suspension is placed in a single oral softgelatin capsule.  
     
     
         10 ) A method according to  claim 1 , wherein the estrogenic substance is formed into a first single oral unit, and the cruciferous indole compound is formed into a second single oral unit.  
     
     
         11 ) A method according to  claim 10 , wherein a number of first single oral units are placed in a first container, and a number of the second single oral units are placed in a second container.  
     
     
         12 ) The method of  claim 11 , wherein the first and second containers are packaged together.  
     
     
         13 ) The method of  claim 10 , wherein the first and second single oral units are a tablet.  
     
     
         14 ) The method of  claim 10 , wherein the first and second single oral units are a capsule.  
     
     
         15 ) The method of  claim 10 , wherein the second single oral unit is a softgelatin capsule.  
     
     
         16 ) The method of  claim 1 , wherein the estrogenic substance is administered orally to the patient in one daily dose of at least 0.03 milligrams per day.  
     
     
         17 ) The method of  claim 1 , wherein the cruciferous indole compound is administered orally to the patient in one daily dose containing at least 5 milligrams of any compound selected from the group consisting of: indole 3-carbinol and diindolyl methane.  
     
     
         18 ) The method of  claim 10 , wherein binders and carriers are used in the first and second oral units to facilitate the administration of the estrogenic substance component and the cruciferous indole compound component.  
     
     
         19 ) A method according to  claim 1  wherein said derivatives include a compound selected from the group consisting of: 5-methyl-indole-3-carbinol, 5-ethyl-indole-3-carbinol, 5-propyl-indole-3-carbinol, 5-butyl-indole-3-carbinol, 5-pentyl-indole-3-carbinol, 5-methoxy-indole-3-carbinol, 5-ethoxy-indole-3-carbinol, 5-propyloxy-indole-3-carbinol, 5-butyloxy-indole-3-carbinol, 5-amyloxy-indole-3-carbinol, N-methyl-indole-3-carbinol, N-ethyl-indole-3-carbinol, N-propyl-indole-3-carbinol, N-butyl-indole-3-carbinol, N-pentyl-indole-3-carbinol, 2-methyl-indole-3-carbinol, 2-ethyl-indole-3-carbino, 2-propyl-indole-3-carbinol, 2-butyl-indole-3-carbinol and 2-pentyl-indole-3-carbinol.  
     
     
         20 ) A process in estrogen replacement therapy comprising the steps of: 
 a) providing a combination comprising: 
 i) an estrogenic substance component; and  
 ii) a cruciferous indole compound component, and  
   b) introducing said composition into a human body that is afflicted with an deficiency of an estrogenic substance,    wherein the total mass of said combination introduced into said body is in the range of 0.1 milligrams and 1,000 milligrams, including every hundredth of a milligram therebetween, per introduction, and wherein said introducing is undertaken orally, buccally, dermally, enterally, parenterally, or by means of a patch.