A randomized double-blind trial was carried out with itraconazole versus placebo in the treatment of vaginal candidiasis, confirmed by clinical evaluation, direct microscopic examination and Sabouraud culture. Fifty patients were studied, 25 in the itraconazole group and 25 in the placebo group. Both groups received two capsules once daily (100 mg itraconazole/cap) for 3 days. One week after treatment patients were re-evaluated according to the same parameters as in selection. The scores for clinical symptoms, leukorrhea, vulvar pruritus, vaginitis and vulvitis, were compared in both groups before and after treatment. Statistically significant differences were found for the itraconazole group in pruritus and vaginitis (P less than 0.05) and vulvitis (P less than 0.001), with no significant difference for leukorrhea. As to the mycological evaluation, 7 days after treatment there were negative results for the itraconazole group in 92% of the patients in comparison to 52% in the placebo group (chi-square, P = 0.005).