Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Completed
Padagis LLC
N/A
2002-12-01
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.
Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis
Completed
Perrigo Company
N/A
2002-12-01
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.
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 Vagin
Completed
Janssen-Cilag, S.A.
Phase 3
2007-12-01
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).
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