Abstract

ACIDFORM is a gel already shown to be safe in vaginal use during six consecutive days through colposcopic observation. A randomized, blinded, crossover study was carried out to compare the spermicidal effect of ACIDFORM to that of a commercial 2% nonoxynol-9 (N-9) product. Twenty sexually active, sterilized women, aged 19–45 years, with regular cycles, normal gynecological exam, no previous sexually transmitted infection (STI) and stable partner willing to undergo four postcoital tests (PCTs) at midcycle during four different menstrual cycles, were enrolled in the study. Known allergy to N-9 or ACIDFORM, oligospermic partner, chronic diseases, use of hormones, previous treatment for STI or presence of STI at screening tests were criteria for exclusion. ACIDFORM or N-9 product administered 0–30 min precoitus or ACIDFORM given 8–10 h precoitus significantly reduced the mean number of progressively motile sperm compared to control cycles (0.19, 0.07, 0.75 vs. 17.94, respectively, p<.05, Wilcoxon test). All treated cycles had five or fewer progressively motile sperm in midcycle cervical mucus, confirming in vivo the spermicidal effect of ACIDFORM previously observed in vitro and in animal models.

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