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Zazole (Terconazole Vaginal) - Summary



Zazole® Vaginal Suppositories (terconazole vaginal suppositories, 80 mg) are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis -1-[ p -[[2-(2,4-Dichlorophenyl)-2-(1 H -1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole.

Zazole® Vaginal Suppositories are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole® Vaginal Suppositories are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.

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Published Studies Related to Zazole (Terconazole Vaginal)

[Effectiveness and safety of ciclopirox olamine 1% vaginal cream versus terconazole 0.8% vaginal cream in the treatment of genital candidiasis] [2000.04]
A multicenter randomized study was performed. One hundred and seventy patients were selected.We conclude that both treatments are effective and well tolerated for genital candidiasis treatment.

Single dose oral fluconazole vs intravaginal terconazole in treatment of Candida vaginitis. Comparison and pilot study. [1992.10]
Candida vaginitis develops in approximately one-fourth of women in their childbearing years...

Terconazole for the treatment of vulvovaginal candidiasis. [1990.11]
A double-blind, randomized trial was conducted to evaluate the efficacy and safety of terconazole for vulvovaginal candidiasis. Treatment consisted of daily intravaginal application of one of the following regimens: 80-mg terconazole suppositories for 3 days, miconazole nitrate suppositories for 7 days or placebo suppositories for 7 days...

[Terconazole in vaginal candidiasis. A comparative study] [1990.11]
The antimycotic action and tolerance to terconazole in patients with vaginal candidiasis, were evaluated in a blind study. The medication was given in vaginal ovules (VO)240 mg, one dose per day, and 80 mg one daily dose for three days; as compared to chlotrimazole, VO 200 mg, daily dose for three days...

A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis. [2015]
Terconazole is a new, broad-spectrum, triazole antifungal agent. The aim of this study was to compare the efficacy and safety of a 6-day course of a terconazole vaginal suppository (80 mg) with two doses of oral fluconazole (150 mg) for the treatment of severe vulvovaginal candidiasis (SVVC)... This study demonstrated that a terconazole vaginal suppository (80 mg daily for 6 days) was as effective as two dose of oral fluconazole (150 mg) in the treatment of patients with SVVC; as such, terconazole could be a choice for therapy of this disorder.

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Clinical Trials Related to Zazole (Terconazole Vaginal)

Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis [Completed]
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.

Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis [Completed]
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis [Completed]
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of the vagina) or bacterial vaginosis (polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli).

Multi-Center Study of New Medications to Treat Vaginal Infections [Recruiting]

Multi-Center Study of New Medications to Treat Vaginal Infections [Recruiting]

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Page last updated: 2015-08-10

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