Vablys® Efficacy Data
Vablys® demonstrated comparable efficacy to clindamycin in a randomized, single-masked, prospective, multi-center, two-arm, parallel-group, active controlled, two-stage adaptive, non-inferiority (15% margin) clinical trial conducted in 15 centers1,2†
- In the per-protocol analysis, Vablys® 10 mg dequalinium chloride tablet, intravaginal, one tablet daily for 6 days was as effective as clindamycin 2% cream (100 mg clindamycin per dose), intravaginal, one dose daily for 7 days, with respective clinical cure rates of 81.5% (n=110) and 78.4% (n=91), showing no statistically significant difference (p=0.00019)1,2†
- The primary efficacy outcome was clinical cure at C1, the first follow-up visit (7 days after the end of treatment), defined as the absence of clue cells and a negative result for at least 2 other Amsel criteria2
- A randomized, single-masked, prospective, multi-center, two-arm, parallel group, active-controlled, two-stage adaptive, non-inferiority (15% margin) clinical trial conducted in 15 centers (n = 321 women) randomized to receive either vaginal 10 mg Vablys® tablets for 6 days (n-164) or vaginal clindamycin 2% cream (100 mg clindamycin per dose) for 7 days (n=157). Follow-up visits were 1 week and 1 month after treatment. Clinical cure based on Amsel’s criteria was the primary outcome. Secondary outcomes were rate of treatment failures and recurrences, incidence of post-treatment vulvovaginal candidosis (VVC), lactobacillary grade (LBG), total symptom score (TSC), and safety. To be included in the study, women had to be diagnosed with BV, for which all 4 Amsel criteria had to be present: (1) characteristic grey, homogeneous, malodorous discharge, (2) pH > 4.5, (3) a positive KOH test for amines, and (4) clue cells (positive if ≥ 20% of the epithelial cells of the wet mount were clue cells).