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(s) targeted: Vaginitis; Infectious Vaginosis

Intervention: Gynoclin V (Drug); Vagitrol V (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen-Cilag, S.A.

Official(s) and/or principal investigator(s):
Janssen-Cilag S.A. Clinical Trial, Study Director, Affiliation: Janssen-Cilag, S.A.

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).

Official title: A Prospective, Open-Label, Comparative, Parallel Double-Arm, Multicentric Clinical Study to Evaluate the Efficacy of an Ovule With Triple Active Agents (Terconazole, Clindamycin, Fluocinolone) Administered Once Per Day for Three Days Versus an Ovule With Triple Active Agents (Metronidazole, Nystatin, Fluocinolone) Administered Once Per Day for Ten Days to Treat Secondary Vulvar/Vaginal Symptoms of Vaginitis/Infectious Vaginosis (Bacterial and/or Mycotic and/or Parasitic)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment

Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment

Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment

Secondary outcome:

Percentage of Participants With Response to Treatment Assessed by Participant

Percentage of Participants With Response to Treatment Assessed by Physician

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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)

DF, Mexico

Mexico D.F., Mexico

Starting date: December 2007
Last updated: November 1, 2013