Single Oral Dose Fluconazole Compared With Conventional Clotrimazole Topical Therapy of Candida Vaginitis. Fluconazole Vaginitis Study Group

Am J Obstet Gynecol. 1995 Apr;172(4 Pt 1):1263-8. doi: 10.1016/0002-9378(95)91490-0.


Objectives: Candida vaginitis is currently treated with a wide range of intravaginal preparations usually prescribed over several days. Fluconazole with its marked activity against Candida species and favorable pharmacokinetics offered a safe, effective, and convenient alternative to topical therapy in a single-dose regimen.

Study design: We conducted a multicenter, randomized, prospective, single-blinded study of 429 patients with acute Candida vaginitis, comparing the efficacy and safety of a single oral 150 mg dose of fluconazole with 7-day clotrimazole 100 mg vaginal treatment. Posttherapy evaluations and mycologic eradication rates were conducted.

Results: No statistically significant differences were seen between fluconazole and clotrimazole in the clinical, mycologic, or therapeutic responses. At the 14-day evaluation clinical cure or improvement was seen in 94% of fluconazole-treated patients and 97% of clotrimazole-treated patients. Mycologic and therapeutic cures were seen in 77% and 76% of the fluconazole and 72% of the clotrimazole groups, respectively. At the 35-day evaluation 75% of both groups remained clinically cured, and 56% of the fluconazole and 52% of the clotrimazole group were considered therapeutic cures. In both treatment groups patients with a history of recurrent vaginitis (33/84) compared 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 effects only.

Conclusion: Fluconazole administered as a single 150 mg oral dose proved to be as safe and effective as 7 days of intravaginal clotrimazole therapy for Candida vaginitis. Therapy of vaginitis should be individualized, taking into consideration severity of disease, history of recurrent vaginitis, and patient preference.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Administration, Oral
  • Administration, Topical
  • Adolescent
  • Adult
  • Candidiasis, Vulvovaginal / drug therapy*
  • Clotrimazole / administration & dosage*
  • Drug Administration Schedule
  • Female
  • Fluconazole / administration & dosage*
  • Humans
  • Middle Aged
  • Prospective Studies
  • Recurrence
  • United States


  • Fluconazole
  • Clotrimazole