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Gynazole (Butoconazole Nitrate Vaginal) - Summary



GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% contains butoconazole nitrate 2%, an imidazole derivative with antifungal activity.

GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures (see CLINICAL STUDIES).

Note: GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established (see PRECAUTIONS - Pregnancy).

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Published Studies Related to Gynazole (Butoconazole Vaginal)

Butoconazole nitrate 2% for vulvovaginal candidiasis. New, single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate. Gynazole 1 Study Group. [1999.11]
OBJECTIVE: To compare the safety and efficacy of a single vaginal dose of a butoconazole nitrate 2% bioadhesive, sustained-release cream* (butoconazole 1-BSR) with a seven-day schedule of miconazole nitrate vaginal cream 2% (miconazole 7)... CONCLUSIONS: This clinical trial demonstrated that butoconazole 1-BSR is an effective and safe alternative to longer-term therapy with miconazole nitrate (seven days) for vulvovaginal candidiasis.

Comparison of three-day butoconazole treatment with seven-day miconazole treatment for vulvovaginal candidiasis. [1989.07]
In this multicenter, parallel, randomized, investigator-blind trial, we compared the safety and efficacy of a three-day regimen of 2% butoconazole vaginal cream with those of a seven-day regimen of 2% miconazole vaginal cream. Enrolled were 271 nonpregnant women with vulvovaginal candidiasis... The advantage of the shorter butoconazole treatment is increased patient compliance with maintenance of high efficacy.

Vulvovaginal candidosis: comparison of 3-day treatment with 2% butoconazole nitrate cream and 6-day treatment with 1% clotrimazole cream. [1988.09]
Sixty-three women with laboratory confirmed diagnoses of vulvovaginal candidosis were enrolled into this randomized, single-blind, parallel comparison of treatment with 2% butoconazole nitrate cream for 3 days and 1% clotrimazole cream for 6 days. Approximately 1 week after treatment ended both medications had substantially relieved vulvovaginal discharge, itching, burning, erythema and swelling...

An evaluation of butoconazole nitrate 2% site release vaginal cream (Gynazole-1) compared to fluconazole 150 mg tablets (Diflucan) in the time to relief of symptoms in patients with vulvovaginal candidiasis. [2005.12]
BACKGROUND: It is estimated that as many as 13 million cases of vulvovaginal infection occur in the United States annually, the majority of which are the result of Candida albicans infection. The symptoms of vulvovaginal infections are often painful and distressing to the patient. The objective of this study was to compare the time to symptomatic relief of vulvovaginal candidiasis (VVC) with butoconazole nitrate 2% Site Release vaginal cream (Gynazole-1) and oral fluconazole 150 mg tablets (Diflucan)... CONCLUSIONS: Single-dose butoconazole nitrate 2% Site Release vaginal cream provides statistically significant improvement in time to first relief of symptoms in the treatment of VVC compared to fluconazole. There is no difference between these two treatments with respect to total relief of symptoms or reinfection rate. Although there was no significant difference in the incidence of adverse events judged by the investigator to be treatment-related, butoconazole treatment did result in fewer patients experiencing adverse events than fluconazole.

Vaginal retention of 2% butoconazole nitrate cream: comparison of a standard and a sustained-release preparation. [1994.11]
The purpose of this study was to establish the length of time that butoconazole nitrate 2% standard cream and sustained-release cream could be detected in the vagina after a single administration of 5 g of cream that contained 100 mg of butoconazole... The sustained-release cream was demonstrated to be present in the vagina in 7 subjects on the third day, 5 on the fourth day, and 1 on the seventh day, while only 1 subject who received standard cream retained it on the third day and none did so thereafter.

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Clinical Trials Related to Gynazole (Butoconazole Vaginal)

A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations [Completed]
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.

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Page last updated: 2006-02-01

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