Topical testosterone formulations and associated methods

Abstract

A topical testosterone formulation is disclosed. In one aspect, the formulation may include a therapeutically effective amount of micronized testosterone, an arginine ingredient, and a tocopherol ingredient admixed with a poloxamer lecithin organogel. Additional ingredients may be included, such as melatonin, oxytocin, DHEA, and progesterone.

What is claimed is:  
     
         1 . A topical testosterone formulation comprising: 
 a modified poloxamer lecithin organogel carrier having admixed therein,    a therapeutically effective amount of an arginine ingredient,    a testosterone aromatization inhibiting amount of a tocopherol ingredient; and    an amount of micronized testosterone of from about 0.5% w/w to about 25% w/w, wherein application of from about 0.5 g to about 2 g of the formulation to the skin, produces physiologic testosterone serum levels in an individual having sub-physiologic testosterone serum levels.    
     
     
         2 . The formulation of  claim 1 , peak serum testosterone concentrations are attained at about 24 to 36 hours after administration of the formulation.  
     
     
         3 . The formulation of  claim 1 , wherein the amount of arginine ingredient is from about 0.1% w/w to about 20% w/w of the formulation.  
     
     
         4 . The formulation of  claim 3 , wherein the amount of arginine ingredient is from about 5% w/w to about 10% w/w of the formulation.  
     
     
         5 . The formulation of  claim 1 , wherein the arginine ingredient is in a salt form.  
     
     
         6 . The formulation of  claim 5 , wherein the arginine ingredient is L-arginine monochloride.  
     
     
         7 . The formulation of  claim 1 , wherein the amount of tocopherol is from about 0.1% w/w to about 20% w/w of the formulation.  
     
     
         8 . The formulation of  claim 7 , wherein the amount of the tocopherol ingredient is from about 5% w/w to about 10% w/w of the formulation.  
     
     
         9 . The formulation of  claim 1 , wherein the tocopherol ingredient comprises alpha tocopherol.  
     
     
         10 . The formulation of  claim 1 , wherein the tocopherol ingredient comprises gamma tocopherol.  
     
     
         11 . The formulation of  claim 1 , further comprising an effective amount of dehydroepiandrosterone (DHEA).  
     
     
         12 . The formulation of  claim 11 , wherein the DHEA comprises dehydroepiandrosterone sulfate (DHEAS).  
     
     
         13 . The formulation of  claim 11 , wherein the amount of DHEA is about from about 1% w/w to about 20% w/w of the formulation.  
     
     
         14 . The formulation of  claim 1 , further comprising an effective amount of melatonin.  
     
     
         15 . The formulation of  claim 14 , wherein the amount of melatonin is from about 1% w/w to about 20% w/w of the formulation.  
     
     
         16 . The formulation of  claim 1  further comprising an effective amount of progesterone.  
     
     
         17 . The formulation of  claim 16 , wherein the amount of progesterone is from about 1% w/w to about 20% w/w of the formulation.  
     
     
         18 . The formulation of  claim 1  wherein further comprising an effective amount of oxytocin.  
     
     
         19 . The formulation of  claim 18 , wherein the amount of oxytocin is from about 1% w/w to about 20% w/w of the formulation.  
     
     
         20 . The formulation of  claim 1  wherein the amount of testosterone is from about 5% w/w to about 10% w/w, the amount of tocopherol is from about 5% w/w to about 10% w/w, and the amount of arginine is from about 5-10% of the formulation.