Treatment of symptoms associated with bacterial vaginosis

Abstract

The invention relates to the use of saccharide, such as lactose for the preparation of a medicament for the treatment and/or prophylaxis of one or more symptoms caused by bacterial vaginosis, wherein the medicament comprises at least 20 percent by weight of saccharide, and wherein the medicament is substantially free from bacteria. Furthermore, the invention relates to a method for treating one or more symptoms associated with bacterial vaginosis, as well as a pharmaceutical composition comprising the saccharide.

1 . A method for the treatment and/or amelioration of one or more symptoms of bacterial vaginosis, comprising administering to an individual having one or more symptoms of bacterial vaginosis a pharmaceutical dosage unit of 10 mg to 10 g in the form of a vaginal solution or gel, said pharmaceutical dosage unit consisting essentially of at least 20% by weight of lactose monohydrate as the only active ingredient, and wherein said dosage unit includes less than 10 5  bacteria, thereby treating and/or ameliorating symptoms of bacterial vaginosis. 
     
     
         2 . The method according to  claim 1 , wherein one symptom is unpleasant vaginal odor. 
     
     
         3 . The method according to  claim 1 , wherein a symptom is pruritus of vulva. 
     
     
         4 . The method according to  claim 1 , wherein the lactose monohydrate is substantially not fermented by  Gardnerella vaginalis.    
     
     
         5 . The method according to  claim 1 , wherein the bacterial vaginosis is caused by bacteria selected from  Gardnerella vaginalis , Gram negative rods, and  Mycoplasma hominis.    
     
     
         6 . The method according to  claim 5 , wherein the bacterial vaginosis is caused by bacteria selected from anaerobic Gram negative rods. 
     
     
         7 . The method according to  claim 1 , wherein the pharmaceutical dosage unit is formulated for topical application. 
     
     
         8 . The method according to  claim 1 , wherein the pharmaceutical dosage unit is in the form of a vaginal solution. 
     
     
         9 . The method according to  claim 1 , wherein the pharmaceutical dosage unit is in the form of a vaginal suppository gel. 
     
     
         10 . The method according to  claim 1 , wherein a dosage unit is from 1-5 g. 
     
     
         11 . The method according to  claim 1 , wherein the pharmaceutical dosage unit comprises one or more pharmaceutically acceptable additives and carriers selected from the group consisting of: polyethylene glycols, glycerol, agar agar, carrageenan, modified starches, stearates and water. 
     
     
         12 . A method for reducing vaginal pH to below 4.7, comprising administering to an individual having one or more symptoms of bacterial vaginosis an effective amount of a pharmaceutical dosage unit of 10 mg to 10 g in the form of a vaginal solution or gel for vaginal application said pharmaceutical dosage unit consisting essentially of:
 a) at least 20 percent by weight of lactose monohydrate as the only active ingredient, and   b) optionally one or more pharmaceutically acceptable additives, carriers and/or preservatives,   wherein said dosage unit includes less than 10 5  bacteria.   
     
     
         13 . The method of  claim 12  wherein the vaginal pH is reduced to below 4.5. 
     
     
         14 . The method of  claim 12  further comprising measuring said vaginal pH subsequent to said administering.