Efficacy, safety, and dose-response of a Live Biotherapeutic Product (BGY-1601-VT, vaginal tablet) as a first-line monotherapy in women with acute vaginal infection: a randomized, double-blind, placebo-controlled study

Gynaecological

Percentage of responders, i.e. participants with clinical cure at V2 AND no rescue therapy started before V2.

Percentage of participants with clinical cure at the time point AND no rescue therapy started., Percentage of participants with improved symptoms at the time point, related to D0 (self-assessment): PGI-C scale ≤ 2 AND no rescue therapy started., Percentage of participants with improved symptoms at the time point, related to D0 (as per the investigator’s assessment): CGI-C scale ≤ 2 AND no rescue therapy started., Percentage of participants who started a rescue therapy before the time point., Evolution of each symptom from D0 to the time point, as per the participant’s assessment (resolution / improvement / no change / worsening): Itching / pruritus, burning / irritation, pain, leucorrhea / vaginal discharge., Evolution of each symptom from D0 to the time point, as per the investigator’s assessment (resolution / improvement / no change / worsening): Leucorrhoea / vaginal discharge, edema, erythema, ulceration, pH., Time to resolution of all symptoms present at D0, as reported in the participant’s diary., Time to symptom recurrence after resolution, if applicable, as reported in the participant’s diary., Time to rescue therapy., Number of events / participants with adverse events (Aes), depending on their classification (systemic / local; severe; treatment-emergent)., Quantification of Lcr35 in the vaginal microbiota, from quantitative polymerase chain reaction (qPCR) on vaginal secretions at the time point.

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France, Germany