Outcome measures
bacterial vaginosis
SECONDARY, RECURRENCE, BACTERIAL VAGINOSIS
As we are not aware of any core outcome sets for bacterial vaginosis, the primary outcome measure, collected via web-based questionnaire, was participant reported resolution of bacterial vaginosis symptoms by 2 weeks after randomisation. This reflects clinical practice where diagnosis and management is often based on history and examination. Microbiological resolution of bacterial vaginosis was also evaluated as a secondary endpoint at 2 weeks but not at the follow up assessments at 3 or 6 months. The following secondary outcomes were also captured using web based questionnaires at 2 weeks, 3 months and 6 months: adherence to treatment (2 weeks only), time to reported resolution of bacterial vaginosis symptoms, number of reported bacterial vaginosis episodes and treatment courses and time to first recurrence of symptoms.Those not providing Week 2 and 6-month questionnaire data were contacted by phone to collect the primary outcome and details of symptom recurrence.At baseline and Week 2, participants provided self-taken vaginal samples for microbiological assessment of bacterial vaginosis (microscopy of a gram stained vaginal smear using the Ison-Hay scoring system [Additional results for the secondary outcomes of quality of life, tolerability, acceptability of treatment, healthcare resource usage and cost-effectiveness are reported elsewhere [