Evaluation of a low-dose nonoxynol-9 gel for the prevention of sexually transmitted diseases - A randomized clinical trial

Background: Low-dose nonoxynol-9 products have a potential advantage of red uced toxicity, However, little is known about their efficacy in reducing th e incidence of sexually transmitted diseases (STDs), Goal: To determine the effect that an intravaginal gel containing 52.5 mg o f nonoxynol-9 has on the acquisition of STDs in a cohort of HIV-1-seronegat ive female sea workers in Mombasa, Kenya, Study Design: A randomized double-blind placebo controlled trial was perfor med. Results: In this study, 139 women were randomized to the nonoxynol-9 group and 139 to the placebo group. No significant differences were found between the two study groups in terms of safety outcomes and reported symptoms, ex cept for a lower incidence of vaginal erythema in the nonoxynol-9 group. Th ere was a significantly higher incidence of gonorrhea in the nonoxynol-9 gr oup than in the placebo group. No significant differences were observed bet ween the groups for acquisition of Candida, trichomonas, bacterial vaginosi s, C trachomatis, syphilis, or HIV-1, although the statistical power to det ect differences for some of these STDs was limited. Conclusions: In this randomized placebo-controlled trial of a low-dose nono xynol-9 gel, a significantly higher incidence of gonorrhea was found in the nonoxynol-9 group, but no significant differences between the groups were found for Candida, trichomonas, bacterial vaginosis, C trachomatis, syphili s, or HIV-1.