drugset / Trial / NCT01867164
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
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2007-12
- Primary completion
- 2008-12
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clindamycin | Unknown | 100 mg | Intravenous |
| Subject | Metronidazole | Small molecule | 500 mg | Intravenous |
| Subject | Nystatin | Unknown | 100000 ug/ml | Intravenous |
| Subject | Terconazole | Small molecule | 80 mg | Intravenous |
| Background | fluocinolone acetonide | Small molecule | 0.5 mg | Intravenous |