Methods for assessing vaginal atrophy

Abstract

An array of methods for assessing vaginal atrophy are disclosed. The methods may be used alone or in combination with a treatment or as part of a kit.

What is claimed is: 
     
         1 . A method for identifying urogenital changes associated with vaginal atrophy, the methods comprising:
 a. measuring pH at the labia majora, labia minora, introitus, or combinations thereof;   b. determining brush sensitivity at the introitus;   c. assessing glycogen amount at the introitus;   d. analyzing epithelial cells sampled at the introitus;   e. assessing protein amount testing at the introitus or the labia majora or the labia minora;   f. assessing metabolites amounts at the introitus or the labia majora or the labia minora;   g. assessing histamine amount at the introitus or the labia majora or the labia minora;   h. transcriptomic heat mapping at the labia majora or the labia minora or the introitus; and   i. evaluating gene expression at the labia majora for a set gene probe set.   
     
     
         2 . The method of  claim 1 , wherein the method of measuring pH further comprises using a pH probe. 
     
     
         3 . The method of  claim 1 , wherein the changes in the gene probe set are limited to gene probes associated with collagen expression. 
     
     
         4 . The method of  claim 1 , wherein the changes in the gene probe set are limited to cell cycle progression. 
     
     
         5 . The method of  claim 1 , wherein one or more of the methods are used to assess the extent of vaginal atrophy prior and post a treatment regime. 
     
     
         6 . The method of  claim 5 , wherein the treatment shows an effect of reducing the pH relative to atrophy by 0.1 to 2.0 pH units. 
     
     
         7 . The method of  claim 5 , wherein the treatment shows an effect of reducing pH relative to atrophy by 0.3 units to 1.5 units. 
     
     
         8 . The method of  claim 5 , wherein the treatment results in the introitus having a pH of 3.5 to 5.8 units. 
     
     
         9 . The method of  claim 5 , wherein the treatment is a urogenitally or vaginally applied emollient comprised of estrogen, isoflavones, niacinamide, hyaluronin, panthenol, fatty oils, buffered acids, and mixtures thereof. 
     
     
         10 . The method of  claim 5 , wherein the treatment is an oral or dermal delivery system comprised of estrogen. 
     
     
         11 . The method of  claim 1 , wherein analyzing epithelial cells at the introitus further comprises of measuring the abundance of rete pegs in the hymenal ring, wherein the methods further comprise a treatment, and wherein the treatment shows an effect of increasing the rete abundance by 10 to 100%. 
     
     
         12 . The method of  claim 1 , wherein analyzing epithelial cells at the introitus further comprises of measuring the thickness of the hymenal epithelia, wherein the methods further comprise a treatment, and wherein the treatment shows an effect of increasing the thickness relative to atrophy by 10 to 300%.