Current Medical Research and Opinion 1990-01-01

Single dose therapy of vaginal candidiasis: a comparative trial of fenticonazole vaginal ovules versus clotrimazole vaginal tablets.

A G Lawrence, E T Houang, E Hiscock, M B Wells, E Colli, M Scatigna

Index: Curr. Med. Res. Opin. 12(2) , 114-20, (1990)

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Abstract

An open, randomized comparative clinical trial was performed in 153 patients suffering from symptomatic vaginal candidiasis confirmed by mycological tests. Patients were allocated at random into two groups: the first group (consisting of 75 subjects) was treated with a single vaginal ovule of fenticonazole (600 mg) and the second group (consisting of 78 subjects) was treated with a single vaginal tablet of clotrimazole (500 mg). Therapeutic efficacy was assessed by microbiological and clinical criteria 7 days and 1 month (when possible) after the single dose treatment. At the first follow-up visit, complete disappearance of the signs and symptoms or a highly significant reduction of their intensity was observed in both treatment groups. No significant difference was evident between the two drugs. At 7 days, the mycological tests gave negative results in 92% of the patients in the fenticonazole group and in 88.5% of the patients in the clotrimazole group. The difference between the two treatment groups was again not statistically significant. The second follow-up visit was performed in 55 (73.3%) patients of the fenticonazole group and in 52 (66.7%) patients of the clotrimazole group. The results indicate that 83.6% of patients in the fenticonazole group and 69.2% of patients in the clotrimazole group were still disease free at the time of this visit. Both drugs were well tolerated. Mild, local and short lasting side-effects were reported in only 5 cases of the group treated with fenticonazole.(ABSTRACT TRUNCATED AT 250 WORDS)