Abstract | OBJECTIVE: STUDY DESIGN: The clinical trial was conducted according to a randomized, parallel, investigator-blind, multicenter study design. The patients self-administered the respective creams to the posterior vaginal fornix. Two hundred twenty-three patients started the trial and were analyzed for safety. A total of 205 patients qualified for efficacy analysis, 101 receiving butoconazole 1-BSR and 104 using miconazole 7. Patients receiving butoconazole 1-BSR inserted one applicator full of medication once. Those assigned to receive miconazole 7 inserted one applicator full daily for seven days. Patients were evaluated 7-10 and 30 days after completion of therapy. RESULTS:
Butoconazole 1-BSR rapidly relieved the signs and symptoms of vulvovaginal candidiasis. The proportion of patients with severe symptoms declined from the pretreatment 20% to 6% on the 1st day, to 3% on the 4th day, and to 2-1% on the 5th-7th day after single-dose application. Eight to ten days after treatment completion, clinical symptoms regressed in 92%, and fungal cultures were negative in 87% of patients. At the 30-day posttreatment visit, 88% of patients remained clinically cured, and 74% had negative fungal cultures. In the miconazole 7 group, the proportion of patients with severe symptoms declined from 23% to 19% after the first dose; thereafter, symptom relief proceeded more rapidly. Eight to ten days after treatment completion, clinical symptoms regressed in 92% and fungal cultures were negative in 87% of patients. At the 30-day follow-up examination, 86% patients were clinically cured, and 77% were culture negative. After single-dose butoconazole 1-BSR, severe symptoms receded faster than after the first dose of miconazole 7, and the difference was statistically significant (P = .01). In all other efficacy parameters, the differences between the two groups were not statistically significant. Neither treatment regimen caused significant adverse events. CONCLUSIONS:
|
Authors | D Brown, M R Henzl, R H Kaufman |
Journal | The Journal of reproductive medicine
(J Reprod Med)
Vol. 44
Issue 11
Pg. 933-8
(Nov 1999)
ISSN: 0024-7758 [Print] United States |
PMID | 10589403
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Chemical References |
- Antifungal Agents
- Imidazoles
- butoconazole
- Miconazole
|
Topics |
- Administration, Topical
- Adult
- Antifungal Agents
(administration & dosage)
- Candidiasis, Vulvovaginal
(drug therapy)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Imidazoles
(administration & dosage)
- Miconazole
(administration & dosage)
- Severity of Illness Index
- Treatment Outcome
|