Abstract
Objective To assess the safety of Smugel compared with KY Jelly vaginal lubricatng gel in baboon (Papio anubis) vagina. Methods Ten sexually mature olive female baboons were used in this study. Vaginal pH, blood chemistry, vaginal flora, vaginal and cervical histology were evaluated at baseline and after administration of 15 ml of either Smugel or KY Jelly gel twice a week for 5 weeks to each randomized treatment group. Results Basal vaginal pH was 5.8 ± 0.8. There was no significant difference in the vaginal pH of Smugel compared with KY Jelly treated animals or baseline data ( P >0.05). Similarly, analysis of blood chemistry parameters revealed no significant differences. The most frequently isolated microorganisms both at baseline and during treatment included Corynebacterium glucuronolyticum, C. renale group, Lactococcus raffinolactis, Leuconostoc lactis, Lactobacillus acidophilus, L. fermentum, L. salivarius, Staphylococcus aureus, S. xyloxus, S. hyicus, Aerococus viridians, Escherichia coli and Candida albicans. No detectable histological changes were observed in the vaginal or cervical sections examined. Conclusion Smugel, compared with KY Jelly did not induce any adverse event that may facilitate transmission of sexual transmitted infection (STI) pathogens including HIV.
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