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
Condition: Vaginitis; Infectious Vaginosis
MeSH terms: Communicable Diseases; Infections; Vaginal Diseases; Vaginitis
Study type: Interventional
Phase: Phase 3

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).
    

Detailed description: 
      This is a prospective (study following participants forward in time), open-label (all people
      know the identity of the intervention), randomized (the study drug is assigned by chance),
      comparative, parallel (a clinical trial comparing the response in 2 or more groups of
      participants receiving different treatments) double-arm, multi-center (when more than 1
      hospital or medical school team work on a medical research study) study. The study consists
      of 3 phases: Screening phase on Visit 1 (Day -3/1); Inclusion or treatment phase on Visit 2
      (Day 1); and Treatment or monitoring phase (3 days after treatment) on Visit 3 (Day 7 for
      Gynoclin V and Day 13 for Vagitrol V) and Visit 4 (Day 12 for Gynoclin V and Day 18 for
      Vagitrol V). Participants will be randomly assigned to 1 of the 2 treatment groups: Gynoclin
      V and Vagitrol V. Participants in Gynoclin V group will be administered 1 ovule (containing
      80 milligram [mg] terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide)
      vaginally every 24 hours at night, for 3 days. Participants in the Vagitrol V group will be
      administered 1 ovule (containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and
      100,000.00 microgram/milliliter nystatin) vaginally every 24 hours at night, for 10 days.
      Primarily, participants will be evaluated for signs and symptoms, characteristics of vaginal
      discharge, changes in vulvar region, changes in cervix and presence of bacteria, fungi and/or
      parasites. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Gynoclin V; Vagitrol V
Intervention type(s): Drug; Drug
Intervention description(s): One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.; One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaginitis; Infectious vaginosis; Terconazole; Clindamycin; Fluocinolone; Metronidazole; Nystatin