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 method of treating a disease or condition which is responsive to testosterone therapy comprising the step of: 
 administering a topical testosterone formulation to the skin of a subject, wherein the formulation comprises a modified poloxamer lecithin organogel carrier having admixed therein, an arginine ingredient in an amount of from about 0.1 to about 20% w/w, and a tocopherol ingredient in an amount of from about 0.1 to about 20% w/w; and    a therapeutically effective amount of micronized testosterone.    
     
     
         2 . The method of  claim 1 , wherein said disease or condition is AIDS Wasting Syndrome.  
     
     
         3 . The method of  claim 1 , wherein said disease or condition is micropenis.  
     
     
         4 . The method of  claim 1 , wherein said disease or condition is a member selected from the group consisting of: somatopause, andropause, viropause, or androgen deficiency in adult males (ADAM).  
     
     
         5 . The method of  claim 1 , wherein said disease or condition is a member selected from the group consisting of: anemia from renal dialysis or chronic kidney disease.  
     
     
         6 . The method of  claim 1 , wherein said disease or condition is benign prostatic hyperplasia.  
     
     
         7 . The method of  claim 1 , wherein said disease or condition is a member selected from the group consisting of: acne, diabetes, infertility, periodontal disease, post anabolic steroid abuse, dry eyes, diabetic retinopathy, retinopathy, and lupus erythematosis.  
     
     
         8 . The method of  claim 1 , wherein said disease or condition is decreased bone density.  
     
     
         9 . The method of  claim 1 , wherein said disease or condition is hyperlipemia.  
     
     
         10 . The method of  claim 1 , wherein the disease or condition is a predisposition toward prostrate cancer.  
     
     
         11 . The method of  claim 1 , wherein said disease or condition is a member selected from the group consisting of: heart disease, angina, and hypertension.  
     
     
         12 . The method of  claim 1 , wherein the disease or condition results in infrequent early morning erections.  
     
     
         13 . The method of  claim 1 , wherein the disease or condition results in small penis size in prepubertal boys.  
     
     
         14 . The method of  claim 1 , wherein the disease or condition results in subphysiologic levels of insulin-like growth factor (IGF-1).  
     
     
         15 . The method of  claim 1 , wherein the disease or condition results in poor muscle strength, cognitive function, mood, and energy, in the subject.  
     
     
         16 . The method of  claim 1  wherein the disease or condition is the result of anabolic steroid abuse.  
     
     
         17 . The method of  claim 1 , wherein the formulation has a testosterone content of about 10% w/w, and administration is a routine of administering from about 0.5 g to about 2 g of the formulation once a day on a daily basis for at least about 30 days.  
     
     
         18 . The method of  claim 17 , wherein the administration achieves a serum testosterone level of from about 600 ng/dl to about 1200 ng/dl.  
     
     
         19 . The method of  claim 1 , wherein the administration comprises applying the formulation to hairless skin along the rib area below the armpit and the underarm and/or to the scrotal skin.  
     
     
         20 . The method of  claim 1 , wherein the administration results in peak levels of serum or salivary testosterone within about 24 to about 36 hours after application.  
     
     
         21 . The method of  claim 1 , wherein the administration results in sufficiently high salivary levels of free testosterone and dihydrotestosterone to prevent the conversion of excess testosterone to estradiol.  
     
     
         22 . A method of temporarily and reversibly decreasing sperm count comprising the step of: 
 administering a topical testosterone formulation to the skin of a male, wherein the formulation comprises a modified poloxamer lecithin organogel carrier having admixed therein, an arginine ingredient in an amount of from about 0.1 to about 20% w/w, and a tocopherol ingredient in an amount of from about 0.1 to about 20% w/w, and a therapeutically effective amount of micronized testosterone.