Table 1 Summary of study endpoints
A | ||
 Primary endpoint |  Secondary endpoints | |
Local tolerability of medical devices (defined as a cumulative sum score of solicited local ADEs between visit 2 and visit 4) | Secondary tolerability endpoints:   solicited and unsolicited adverse events and ADEs   global assessment of tolerability   leucocytes in vaginal smear | |
Secondary efficacy endpoints:   assessment of biofilm/EPS   percentage of patients with clue cells   changes in vaginal pH values   changes in Nugent score   changes in vaginal flora   global judgment of patient and investigator recurrence of BV during the 12-week follow-up phase | ||
B | ||
 Excluded women (n = 72) |  Included women (n = 44) | |
No biofilm and/ or No EPS and/ or Nugent score < 7 and/ or other reason (e.g., smoking) | Age (mean) | 32.4 years (range 19–51 years) |
Ethnicity | 83.7% Caucasian, 11.6% with African descent | |
Previous vulvovaginal diseases | 39.5% (23.3% BV, 2.3% candidiasis, 16.3% unidentified vaginal infection or dybiosis) | |
Miscarriage or preterm birth | 7.0% | |
Systemic hormonal contraceptives | 48.8% | |