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news.Starpharma has started a Phase 2 trial to evaluate VivaGel as a preventive measure for bacterial vaginosis (BV).
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The trial expects to evaluate women with a prior history of recurrent BV, and the product will be used every second day.
The company will recruit around 200 women in the trial.
The primary objective of the study is to determine the efficacy of two strengths of VivaGel (1% and 3%) compared with a placebo gel in preventing recurrence of BV.
In previous trial, VivaGel showed that the product successfully treated patients suffering the illness, with very high levels of patient acceptability.
Starpharma CEO Jackie Fairley said in addition to the obvious unmet market need for the recurrence indication, they were very encouraged by the results obtained in their Phase 2 BV treatment trial of VivaGel reported in May, and the implications of these results for recurrence.