Mucosal integrity and inflammatory markers in the female lower genital tract as potential screening tools for vaginal microbicides.

ABSTRACT

BACKGROUND: In the female genital tract, vaginal colposcopy, endometrial mucosal integrity and inflammatory mediators are potential in vivo biomarkers of microbicide and contraceptive safety. STUDY DESIGN: A randomized, blinded crossover trial of 18 subjects comparing effects of nonoxynol-9 vaginal gel (Gynol II; putative inflammatory gel), hydroxyethyl cellulose gel (HEC; putative inert gel) and no gel exposure on endometrial and vaginal epithelial integrity and endometrial and vaginal inflammatory markers [interleukin (IL) 1ß, IL-6, IL-8, MCP-1, MIP-1α, MIP-1ß, RANTES, tumor necrosis factor α, IL-1RA, IL-10, SLPI). RESULTS: Gynol II was associated with more vaginal lesions. No endometrial disruptions were observed across conditions. In the vagina, RANTES (p=.055) and IL-6 (p=.04) were higher after HEC exposure than at baseline. In the endometrium, IL-1ß (p=.003) and IL-8 (p=.025) were lower after Gynol II cycles than after no gel. CONCLUSIONS: Gynol II and HEC may modulate inflammatory markers in the vagina and endometrium. How these changes relate to infection susceptibility warrants further study.