Evaluation of a Low-Dose Nonoxynol-9 Gel for the Prevention of Sexually Transmitted Diseases: A Randomized Clinical Trial

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BackgroundLow-dosenonoxynol-9 products have a potential advantage of reduced toxicity. However,little is known about their efficacy in reducing the incidence of sexuallytransmitted diseases(STDs).GoalTodetermine the effect that an intravaginal gel containing 52.5 mg ofnonoxynol-9 has on the acquisition of STDs in a cohort ofHIV-1–seronegative female sex workers in Mombasa,Kenya.StudyDesignA randomized double-blind placebo controlled trialwasperformed.ResultsInthis study, 139 women were randomized to the nonoxynol-9 group and 139 to theplacebo group. No significant differences were found between the two studygroups in terms of safety outcomes and reported symptoms, except for a lowerincidence of vaginal erythema in the nonoxynol-9 group. There was asignificantly higher incidence of gonorrhea in the nonoxynol-9 group than inthe placebo group. No significant differences were observed between the groupsfor acquisition of Candida, trichomonas, bacterial vaginosis, Ctrachomatis, syphilis, or HIV-1, although the statistical power todetect differences for some of these STDs waslimited.ConclusionsInthis randomized placebo-controlled trial of a low-dose nonoxynol-9 gel, asignificantly higher incidence of gonorrhea was found in the nonoxynol-9group, but no significant differences between the groups were found for Candida, trichomonas, bacterialvaginosis, C trachomatis, syphilis, orHIV-1.

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