A PLACEBO-CONTROLLED, DOUBLE-BLIND PROSPECTIVE-STUDY IN HEALTHY FEMALE VOLUNTEERS OF DEXTRIN SULFATE GEL - A NOVEL POTENTIAL INTRAVAGINAL VIRUCIDE

A double-blind, placebo-controlled study was designed to evaluate the safety and tolerability of intravaginal dextrin sulphate (D2S) gel to assess its preliminary suitability as a potential vaginal virucide. To lerability was assessed by questionnaire and patient interview. Colpos copy with vaginal biopsy was performed to assess the macroscopic and m icroscopic evidence of inflammation. The potential impact of the gel o n normal vaginal flora was examined by quantitative lactobacilli cultu re with assessment of the ratio of peroxide to nonperoxide producing o rganisms. Colposcopy revealed mild erythema in five of 24 subjects rec eiving active gel and in none of the 12 placebo recipients, but histol ogy in all subjects revealed no evidence of inflammation. No impact on vaginal lactobacilli was found. We conclude that D2S gel is safe and well tolerated intravaginally at the dosing schedule used in this stud y.