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May 30, 2011
StarPharma reported results from a phase II trial of VivaGel for the treatment of bacterial vaginosis. This double-blind, randomized, placebo controlled, dose-ranging study enrolled 132 women who received 0.5%, 1% or 3% gel or placebo gel administered vaginally for seven consecutive days. The primary endpoint was Clinical Cure as defined by no abnormal discharge. VivaGel 1% resulted in 74% of subjects achieving Clinical Cure two to five days after completion of therapy compared with 22% in the placebo group (P≡0.0002). This effect was sustained: two to three weeks after completion of therapy, 46% of subjects achieved Clinical Cure compared with 12% for the placebo (P≡0.006). In addition, unpleasant vaginal odor was cured in 78% of the VivaGel treated subjects. The incidence of adverse events was similar across all placebo gel and VivaGel groups.
April 1, 2002
Results were reported from a phase II randomized, placebo-controlled trial evaluating CTV-05, a strain of human Lactobacillus, for treatment of bacterial vaginosis. The drug was tested in over 400 female subjects as an adjunct to standard metronidazole therapy. Treatment with CTV-05 resulted in vaginal colonization by lactobacillus crispatus in 62% of subjects at 30 days, compared to only 2% of placebo subjects. However, clinical cure rates at 30 days, the primary endpoint of the trial, were not significantly improved with CTV-05 treatment. Satisfactory cure rates were reported in approximately 50% of subjects in both groups. Clinical cure at 30 days was observed in 70% of colonized subjects who received the active drug, compared to 47% who were non-colonized and received placebo, showing that while CVT-05 does not significantly improve cure rates, it does significantly increase colonization rates. CVT-05 is being developed by The Medicines Company.