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Table 1 Summary of study endpoints

From: Treatment of biofilms in bacterial vaginosis by an amphoteric tenside pessary-clinical study and microbiota analysis

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%
  1. ADE adverse device event