Compositions for preventing hormone induced adverse effects

Abstract

A unit dosage form suitable for once daily administration to a human comprising a physiologically effective amount of at least one hormone selected from the group consisting of steroidal estrogen, estradiol, estrone, medroxyprogesterone, norethindrone, norethisterone, progestin, norgestrel, and progesterone, and at least one carotenoid wherein said carotenoid is in an amount effective to prevent adverse effects which may result from the administration of said hormone.

What is claimed is:  
     
         1 . A unit dosage form composition suitable for once daily administration to a human, comprising 
 a physiologically effective amount of at least one phytoestrogen and    at least one carotenoid selected from the group consisting of zeta-carotene, phytoene, phytofluene, lutein, zeaxanthin, and astazantine, wherein said carotenoid is in an amount of about 2 mg, or an amount sufficient to cause effective serum concentrations of said carotenoid of up to about 1.5 μM, and    wherein said composition is substantially free of any other active component.    
     
     
         2 . The unit dosage form composition of  claim 1 , wherein said carotenoid is present in an amount of about 2 mg.  
     
     
         3 . The unit dosage form composition of  claim 1 , wherein said carotenoid is present in an amount sufficient to cause effective serum concentrations of said carotenoid of up to about 1.5 μM.  
     
     
         4 . A unit dosage form suitable for once daily administration to a human, comprising 
 a physiologically effective amount of at least one phytoestrogen and    a mixture of lycopene and phytoene, wherein said mixture is in an amount of about 2 mg, and    wherein said composition is substantially free of any other active component.    
     
     
         5 . A unit dosage form suitable for once daily administration to a human, comprising 
 a physiologically effective amount of at least one phytoestrogen and    a mixture of lycopene and phytofluene, wherein said mixture is in an amount of about 2 mg, and    wherein said composition is substantially free of any other active component.    
     
     
         6 . A unit dosage form suitable for once daily administration to a human, comprising 
 a physiologically effective amount of at least one phytoestrogen and    a mixture of lycopene, phytoene and phytofluene, wherein said mixture is in an amount of about 2 mg, and    wherein said composition is substantially free of any other active component.    
     
     
         7 . A method for reducing undesirable effects inherent in hormone replacement therapy (HRT) while simultaneously providing positive effects of HRT, comprising administering, to a woman in need thereof, the unit dosage form composition of  claim 1 , once daily.  
     
     
         8 . A method for providing beneficial effects of a phytoestrogen while simultaneously reducing the risk for developing hormone-dependent cancer inherent in the administration of said phytoestrogen, said method comprising 
 administering, once daily, to a person in need of the administration of a phytoestrogen, the unit dosage form composition of  claim 1 , and in the absence of administration of a phytoestrogen from another source.    
     
     
         9 . A method for the administration of a phytoestrogen while simultaneously inhibiting additive adverse effects on cell proliferation incurred by elevated levels of growth factor IGF-1 hormone intake, comprising 
 administering to a patient with elevated IGF-1 levels the unit dosage form composition of  claim 1 , once daily.    
     
     
         10 . A method for reducing undesirable effects inherent in hormone replacement therapy (HRT) while simultaneously providing positive effects of HRT, comprising administering, to a woman in need thereof, the unit dosage form composition of  claim 4 , once daily.  
     
     
         11 . A method for providing beneficial effects of a phytoestrogen while simultaneously reducing the risk for developing hormone-dependent cancer inherent in the administration of said phytoestrogen, said method comprising 
 administering, once daily, to a person in need of the administration of a phytoestrogen, the unit dosage form composition of  claim 4 , and in the absence of administration of a phytoestrogen from another source.    
     
     
         12 . A method for the administration of a phytoestrogen while simultaneously inhibiting additive adverse effects on cell proliferation incurred by elevated levels of growth factor IGF-1 hormone intake, comprising 
 administering to a patient with elevated IGF-1 levels the unit dosage form composition of  claim 4 , once daily.    
     
     
         13 . A method for reducing undesirable effects inherent in hormone replacement therapy (HRT) while simultaneously providing positive effects of HRT, comprising administering, to a woman in need thereof, the unit dosage form composition of  claim 5 , once daily.  
     
     
         14 . A method for providing beneficial effects of a phytoestrogen while simultaneously reducing the risk for developing hormone-dependent cancer inherent in the administration of said phytoestrogen, said method comprising 
 administering, once daily, to a person in need of the administration of a phytoestrogen, the unit dosage form composition of  claim 5 , and in the absence of administration of a phytoestrogen from another source.    
     
     
         15 . A method for the administration of a phytoestrogen while simultaneously inhibiting additive adverse effects on cell proliferation incurred by elevated levels of growth factor IGF-1 hormone intake, comprising 
 administering to a patient with elevated IGF-1 levels the unit dosage form composition of  claim 5 , once daily.    
     
     
         16 . A method for reducing undesirable effects inherent in hormone replacement therapy (HRT) while simultaneously providing positive effects of HRT, comprising administering, to a woman in need thereof, the unit dosage form composition of  claim 6 , once daily.  
     
     
         17 . A method for providing beneficial effects of a phytoestrogen while simultaneously reducing the risk for developing hormone-dependent cancer inherent in the administration of said phytoestrogen, said method comprising 
 administering, once daily, to a person in need of the administration of a phytoestrogen, the unit dosage form composition of  claim 6 , and in the absence of administration of a phytoestrogen from another source.    
     
     
         18 . A method for the administration of a phytoestrogen while simultaneously inhibiting additive adverse effects on cell proliferation incurred by elevated levels of growth factor IGF-1 hormone intake, comprising 
 administering to a patient with elevated IGF-1 levels the unit dosage form composition of  claim 6 , once daily.