Introduction: Bacterial Vaginosis (BV) is an imbalance in the naturally occurring vaginal bacterial flora resulting in lack of vaginal acidity, inhibition of the normal lactobacilli growth and overgrowth by mixed anaerobic bacterial flora including Gardnerella vaginalis. The prevalence of BV is estimated at approximately 15-30% among fertile women and frequent recurrences several times a year are common. BV has a negative effect on many women's lives, in particular due to the odorous vaginal discharge. First line treatment with antibiotics is associated with adverse events, high relapse rates, and an emerging risk of bacterial drug resistance development. New antibiotic-free treatments with high efficacy and less frequent administration in combination with high patient acceptance are needed.The aim of the present study was to investigate a new sustained release treatment, an Oligomeric Lactic Acid (OMLA) pessary in patients with confirmed BV, and to evaluate BV clearance, pH decrease, adverse events, and patient treatment satisfaction.
Methods:The study was a randomized parallel-group open-label two-part study at ten gynecological clinics. Part A: A two-week proof-of-concept evaluation, and Part B: A one-week efficacy evaluation. In Parts A and B, the OMLA pessary was administrated either Once (OW) or Twice (TW) a week and in Part B was also compared to an untreated Control Group (CG). Non-pregnant fertile women with confirmed BV could participate. The main outcome measures were Amsel's criteria to confirm BV, vaginal pH, adverse events, and patient treatment satisfaction.Results: Part A (n=21) showed high safety and treatment efficacy already after one week. In the pooled treatment group, the one week BV clearance ratio was 19/20 (95%). In Part B (n=105) the one week BV clearance ratios were 70.6% in the OW group (p<0.001 vs. CG), 80.0% in the TW group (p<0.001 vs. CG), and 10.0% in the CG. Pooled data from Parts A and B showed a one week BV clearance of 78% in each treatment group. The vaginal pH decreased (p<0.05) in both treatment groups. The results demonstrated high patient treatment satisfaction. Most adverse events were mild and of short duration.
Conclusion:The novel OMLA pessary showed a BV treatment efficacy of 78% after one week of single-dose administration. Along with a good safety profile, user-friendliness, and no risk of bacterial antibiotic resistance development, this represents a significant improvement in BV treatment.