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

• Status: Completed
• Trial end date: 2008-12-01

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).

• Phase: Phase 3

Details

• Lead Sponsor: Janssen-Cilag, S.A.
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Fluocinolone Acetonide; Metronidazole; Nystatin; Terconazole