[Efficacy and tolerance of 200 mg of fenticonazole versus 400 mg of miconazole in the intravaginal treatment of mycotic vulvovaginitis].

OBJECTIVE

Fenticonazole is an imidazole derivative with a broad-spectrum antifungal activity mainly against Candida albicans. Fenticonazole nitrate was compared to myconazole vs. test efficacy, tolerance and treatment compliance in-patients with mycotic vulvovaginitis.

PATIENTS AND METHOD

Eighty outpatients with mycotic vulvovaginitis were included and randomly placed in two groups of forty patients each one. Each group was either given 200 mg of fenticonazole nitrate intravaginal ovules or 400 mg of myconazole vaginal ovules on a daily basis for three days. Before the pharmacological treatment, each patient was evaluated clinically and microbiologically, as well as at the end of treatment (day 7-10) and one-month (28 days) after treatment. All patients gave informed consent to participate in the trial.

RESULTS

No statistical differences were found between either treatment group during the anthropometric and demographic evaluation, neither in the signs and clinical symptoms of infection. Both treatment groups were considered as comparable. At after treatment evaluation (7-10 days) it was observed disappearance of almost all symptoms. At the final evaluation this fact was even more evident (day 21-28). At the study's completion, clinical efficacy (symptoms relief) was considered satisfactory in 100% (40/40) of the cases in the fenticonazole group and 97.5% (39/40) of myconazole group (one way ANOVA [GLM] analysis). The microorganisms more frequently isolated as the causing agents of infection in both groups were Candida albicans, 93% in the fenticonazole group and 85% in the myconazole group. Upon the study's completion, the microbiological efficacy was considered as successful in 97.5% of the cases in both groups (chi square [x2] analysis). The patient's compliance to the treatment was considered satisfactory in 100% in the fenticonazole group and 97.5% in the myconazole group. Tolerance was considered excellent in 100% (40/40) of the fenticonazole cases and in 95% (38/40) of the myconazole cases. Nevertheless, 5% (2/40) of the patients in the myconazole group had minor adverse events that did not require treatment suspension. No adverse events were reported in the fenticonazole group.

CONCLUSION

The results showed that both drugs are equally efficient in treating signs and symptoms of the infection as well as equally effective in the microbiological elimination of the causing agents of the mycotic vulvovaginitis.