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
Intervention: Gynoclin V; Vagitrol V
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Vaginitis; Infectious vaginosis; Terconazole; Clindamycin; Fluocinolone; Metronidazole; Nystatin

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants presenting clinical symptoms compatible with vaginitis/bacterial
             vaginosis, with any of the following symptoms being the reason for the consultation:
             pruritus (itchiness), vulvar burning, as well as presenting leukorrhea (a clear or
             white discharge from the vagina, consisting mainly of mucus) as an accompanying
             symptom

          -  Participant who agrees to return at the 7th and 13th day after starting the treatment

          -  Participant who agrees to abstain from sexual relations for the 13 days of the study

          -  Participant who have signed informed consent to participate in the study

        Exclusion Criteria:

          -  Participant with a known allergy to vaginal treatments

          -  Participants who have received treatment for the current condition in the 10 days
             before the date of inclusion, or is currently receiving antibiotics (drug used to stop
             or slow down the growth of germs), antifungals, anti-parasitics or systemic steroids

          -  Participant with suspected pregnancy or currently breastfeeding

          -  Participant who has received unknown drugs or experimental drugs within the 3 months
             before inclusion

          -  Participant known to be a carrier of a severe (very serious, life threatening) disease
             that alters the metabolism or excretion of the drugs used (liver or kidney disease)