Single oral dose fluconazole compared with conventional clotrimazole topical therapy of Candida vaginitis. Fluconazole Vaginitis Study Group.

Abstract

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.

• Authors: J D Sobel, D Brooker, G E Stein, J L Thomason, D P Wermeling, B Bradley, L Weinstein
• Journal: American journal of obstetrics and gynecology (Am J Obstet Gynecol) Vol. 172 Issue 4 Pt 1 Pg. 1263-8 (Apr 1995) ISSN: 0002-9378 [Print] United States
• PMID: 7726267 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Fluconazole
• Clotrimazole

Topics

• 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