SUMMARY
Terconazole vaginal cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole.
Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
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NEWS HIGHLIGHTS
Clinical Trials Related to 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: 2009-08-28
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