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

Phase 3

Completed

• Conditions: Infectious Vaginosis; Vaginitis
• Interventions: Drug: Gynoclin V; Drug: Vagitrol V

• Registration Number: NCT01867164
• Lead Sponsor: Janssen-Cilag, S.A.

Brief 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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-03
• Results First Submitted: 2013-07-12
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-01
• Last Update Submitted: 2013-11-01
• Results First Posted: 2013-12-24
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gynoclin V	Gynoclin V	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.
Vagitrol V	Vagitrol V	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment	8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)	Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment	3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)	Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment.
Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment	3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)	Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Response to Treatment Assessed by Participant	8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)	Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).
Percentage of Participants With Response to Treatment Assessed by Physician	8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)	Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).