Starpharma Holdings has received US Food and Drug Administration (FDA) approval to begin a Phase II study to investigate VivaGel for the treatment of bacterial vaginosis.
More than 130 women are enrolled on the study, which will identify the efficacy and optimal dosing for VivaGel with three strengths (0.5%, 1% and 3%) compared to a placebo gel.
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The trial will observe VivaGel for both short and long-term suppression of bacterial vaginosis recurrence.
Initial phase of the study will analyse a once-daily treatment over seven days.
