Comparative open evaluation of efficacy and tolerability of terconazole 0.8% cream in a 5-day regimen versus clotrimazole 100-mg tablets in a 6-day regimen.

Abstract

This open-ended study was performed to compare the therapeutic effect and the clinical tolerability of a 5-day treatment with terconazole 0.8% cream with that of 6 days with clotrimazole 100-mg vaginal tablets. 75 patients on terconazole and 73 subjects on clotrimazole were studied, all of whom had positive cultures on Nickerson’s medium before treatment. Subjective symptoms and objective signs of vaginal candidosis and mycological findings were evaluated 1 and 4 weeks after completion of therapy. Before treatment, 92% of the patients in each treatment group had been suffering from pruritus, 77% from burning/irritation, and 96% from vaginal discharge. 1 week after completion of therapy, pruritus was present in 25%, burning/irritation in 23%, and vaginal discharge in 32% of the cases on terconazole. In the clotrimazole group, 15% had pruritus, 16% burning/irritation and 28% vaginal discharge. 4 weeks after completion of therapy, 15% of the subjects on terconazole had pruritus, 13% burning/irritation, and 18% vaginal discharge; in the clotrimazole group, the corresponding percentages were 12, 13 and 23%. Mycological cure rates at 1 week were 83% in the terconazole group and 89% in the clotrimazole group. 4 weeks after completion of therapy, 13% of the mycologically cured terconazole patients and 22% of the mycologically cured clotrimazole patients were positive again. Local treatment with terconazole was well tolerated by all patients, while 3 on clotrimazole complained of burning and pruritus. Of the 69 pregnant women treated, the status of mother and child at delivery was evaluated in 67. No drug-related abnormalities were noted.