Method of treatment and prevention of bacterial vaginosis

Abstract

Described herein are methods of reducing the risk of recurrence of bacterial vaginosis by intravaginal administration of compositions comprising L-lactic acid, polymer thickener, and preservative.

1 . A method of treating bacterial vaginosis (BV) comprising intravaginally administering a composition to a subject with BV, wherein the composition comprises: (a) a polymer thickener; (b) about 2.5% w/v L-lactic acid; (c) a preservative, d) citric acid, (e) potassium bitartrate, (f) a humectant, (g) a pH adjusting agent, and (h) a solvent, wherein the composition is administered multiple times during a course of treatment, wherein the course of treatment comprises about 1 week to about 20 weeks, wherein the composition is administered at a dosage from about 0.5 g to about 10 g per dose, and wherein administering the composition ameliorates symptoms of BV in the subject. 
     
     
         2 . The method of  claim 1 , wherein the solvent is water. 
     
     
         3 . The method of  claim 1 , wherein the course of treatment comprises an initial course of treatment and a subsequent course of treatment and wherein the composition is administered more frequently during the initial course of treatment than during the subsequent course of treatment. 
     
     
         4 . The method of  claim 3 , wherein the frequency of administration during the initial course of treatment is daily, less than once daily, every other day, once a week, or once every 2 weeks. 
     
     
         5 . The method of  claim 3 , wherein the frequency of administration during the subsequent course of treatment is less than once daily, every other day, once a week, once every 2 weeks, or once every 3 weeks. 
     
     
         6 . The method of  claim 1 , wherein the composition is administered at a dosage from about 3 g to about 5 g, about 3 g, about 4 g, or about 5 g. 
     
     
         7 . The method of  claim 1 , wherein the subject has previously been diagnosed as Amsel-positive. 
     
     
         8 . The method of  claim 7 , wherein upon of administration of the composition the subject is Amsel-negative, thereby treating the BV. 
     
     
         9 . A method of reducing the recurrence rate of bacterial vaginosis (BV) comprising intravaginally administering a composition to a subject, wherein the composition comprises: (a) a polymer thickener; (b) about 2.5% w/v L-lactic acid; (c) a preservative, (d) citric acid, (e) potassium bitartrate, (f) of a humectant, (g) a pH adjusting agent, and (h) a solvent, wherein the composition is administered multiple times during a course of treatment, wherein the course of treatment comprises about 1 week to about 20 weeks, wherein the composition is administered at a dosage from about 0.5 g to about 10 g per dose, and wherein administering the composition reduces recurrence rate of bacterial vaginosis in the subject. 
     
     
         10 . The method of  claim 9 , wherein the subject is a subject with BV. 
     
     
         11 . The method of  claim 10 , wherein the subject with BV is asymptomatic. 
     
     
         12 . The method of  claim 9 , wherein the subject is free of BV. 
     
     
         13 . The method of  claim 9 , wherein the polymer thickener is selected from a group consisting of xanthan gum, alginic acid, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, chitosan, polycarbophil, and carbopol. 
     
     
         14 . The method of  claim 9 , wherein the solvent is water. 
     
     
         15 . The method of  claim 9 , wherein the course of treatment comprises an initial course of treatment and a subsequent course of treatment and wherein the composition is administered more frequently during the initial course of treatment than during the subsequent course of treatment. 
     
     
         16 . The method of  claim 15 , wherein the frequency of administration during the initial course of treatment is daily, less than once daily, every other day, once a week, or once every 2 weeks. 
     
     
         17 . The method of  claim 16 , wherein the frequency of administration during the subsequent course of treatment is less than once daily, every other day, once a week, once every 2 weeks, or once every 3 weeks. 
     
     
         18 . The method of  claim 9 , wherein the composition is administered at a dosage from about 3 g to about 5 g, about 3 g, about 4 g, or about 5 g. 
     
     
         19 . The method of  claim 1 , wherein a pH less than 5 is maintained in the vagina. 
     
     
         20 . The method of  claim 9 , wherein a pH less than 5 is maintained in the vagina.