Successful treatment of bacterial vaginosis with a policarbophil-carbopol acidic vaginal gel: results from a randomised double-blind, placebo-controlled trial

The study was to evaluate the efficacy and safety of MVG in the treatment of BV in non-pregnant women in comparison with placebo. The primary outcome was to compare the clinical and laboratory cure rate between two groups at week 6 (end of treatment phase) and at week 12 (end of follow-up phase). Secondary outcomes were to compare the effects on vaginal pH and the vaginal pH normalization rate. Clinical cure rate was defined as the disappearance of the following signs and symptoms of BV: homogenous vaginal discharge; presence of ≥ 2 or more clue cells at the wet mount microscopy; a Nugent score > 7, a vaginal pH > 4.7 and a positive Whiff test. Normalization of vaginal pH was defined as the percentage of women with a vaginal pH < 4.6.