SINGLE ORAL DOSE FLUCONAZOLE COMPARED WITH CONVENTIONAL CLOTRIMAZOLE TOPICAL THERAPY OF CANDIDA-VAGINITIS

OBJECTIVES: Candida vaginitis is currently treated with a wide range o f intravaginal preparations usually prescribed over several days. Fluc onazole with its marked activity against Candida species and favorable pharmacokinetics offered a safe, effective, and convenient alternativ e to topical therapy in a single-dose regimen. STUDY DESIGN: We conduc ted a multicenter, randomized, prospective, single-blinded study of 42 9 patients with acute Candida vaginitis, comparing the efficacy and sa fety of a single oral 150 mg dose of fluconazole with 7-day clotrimazo le 100 mg vaginal treatment. Posttherapy evaluations and mycologic era dication rates were conducted. RESULTS: No statistically significant d ifferences were seen between fluconazole and clotrimazole in the clini cal, mycologic, or therapeutic responses. At the 14-day evaluation cli nical cure or improvement was seen in 94% of fluconazole-treated patie nts and 97% of clotrimazole-treated patients. Mycologic and therapeuti c cures were seen in 77% and 76% of the fluconazole and 72% of the clo trimazole groups, respectively. At the 35-day evaluation 75% of both g roups remained clinically cured, and 56% of the fluconazole and 52% of the clotrimazole group were considered therapeutic cures. In both tre atment groups patients with a history of recurrent vaginitis (33/84) c ompared with those without a history of recurrent vaginitis (177/266) were significantly less likely to respond clinically and mycologically (p < 0.001). Twenty-seven percent of the fluconazole-treated patients and 17% of the clotrimazole-treated patients reported mild side effec ts only. CONCLUSION: Fluconazole administered as a single 150 mg oral dose proved to be as safe and effective as 7 days of intravaginal clot rimazole therapy for Candida vaginitis. Therapy of vaginitis should be individualized, taking into consideration severity of disease, histor y of recurrent vaginitis, and patient preference.