Objective To determine the safety and efficacy of UniPron as a reversible contraceptive.Methods Vaginal swabs were obtained before and after UniPron administration, cultured onto appropriate culture media and bacteria...Objective To determine the safety and efficacy of UniPron as a reversible contraceptive.Methods Vaginal swabs were obtained before and after UniPron administration, cultured onto appropriate culture media and bacteria identification was done based on type of media used, Gram stain reactions, colony morphology and biochemical tests. Vaginal biopsy tissues were processed using paraffin wax method, stained with hematoxylin and eosin and examined under light microscopy to determine the effect of the product on vaginal tissues. The effect of UniPron on sperm was examined by mixing the product with electroejaculated spermatozoa in vitro at different concentrations. For efficacy studies, male baboons of proven fertility were mated with UniPron treated or untreated females of proven fertility during the fertile stages. Results All the five females （100%） that were treated with UniPron did not conceive and they regained total fertility when the treatment was stopped while all the controls conceived. At a concentration of 40%, UniPron completely immobilized spermatozoa in an in-vitro system. UniPron mechanism of action was by lowering the vaginal pH and on application in baboon, the pH was lowered for at least 3 h after which it went back to normal.Conclusions As we plan for a study to test UniPron as a microbicide to prevent STIs including HIV, our current study has established that this novel product is effective in contraception and harmless to vaginal tissues and vaginal microbial flora in a baboon model （Papio anubis）.展开更多
Objective To assess the safety of Smugel compared with KY Jelly vaginal lubricating gel in baboon （Papio anubis） vagina. Methods Ten sexually mature olive female baboons were used in this study. Vaginal pH, blood ch...Objective To assess the safety of Smugel compared with KY Jelly vaginal lubricating 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 of15 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.展开更多
基金This project was supported through a funded project at the Institute of Primate Research, by the Government of Kenya
文摘Objective To determine the safety and efficacy of UniPron as a reversible contraceptive.Methods Vaginal swabs were obtained before and after UniPron administration, cultured onto appropriate culture media and bacteria identification was done based on type of media used, Gram stain reactions, colony morphology and biochemical tests. Vaginal biopsy tissues were processed using paraffin wax method, stained with hematoxylin and eosin and examined under light microscopy to determine the effect of the product on vaginal tissues. The effect of UniPron on sperm was examined by mixing the product with electroejaculated spermatozoa in vitro at different concentrations. For efficacy studies, male baboons of proven fertility were mated with UniPron treated or untreated females of proven fertility during the fertile stages. Results All the five females （100%） that were treated with UniPron did not conceive and they regained total fertility when the treatment was stopped while all the controls conceived. At a concentration of 40%, UniPron completely immobilized spermatozoa in an in-vitro system. UniPron mechanism of action was by lowering the vaginal pH and on application in baboon, the pH was lowered for at least 3 h after which it went back to normal.Conclusions As we plan for a study to test UniPron as a microbicide to prevent STIs including HIV, our current study has established that this novel product is effective in contraception and harmless to vaginal tissues and vaginal microbial flora in a baboon model （Papio anubis）.
文摘Objective To assess the safety of Smugel compared with KY Jelly vaginal lubricating 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 of15 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.
