Trial record 3 of 135 for:    vaginitis

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT01867164
First received: May 29, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Vaginitis
Infectious Vaginosis
Drug: Gynoclin V
Drug: Vagitrol V
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment [ Time Frame: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) ] [ Designated as safety issue: No ]
    Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.

  • Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment [ Time Frame: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Response to Treatment Assessed by Participant [ Time Frame: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V) ] [ Designated as safety issue: No ]
    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).


Enrollment: 160
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Experimental: 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.
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867164

Locations
Mexico
DF, Mexico
Mexico D.F., Mexico
Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. Clinical Trial Janssen-Cilag, S.A.
  More Information

No publications provided

Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT01867164     History of Changes
Other Study ID Numbers: CR100569, TEROV8BAC4001
Study First Received: May 29, 2013
Results First Received: July 12, 2013
Last Updated: November 1, 2013
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Janssen-Cilag, S.A.:
Vaginitis
Infectious vaginosis
Terconazole
Clindamycin
Fluocinolone
Metronidazole
Nystatin

Additional relevant MeSH terms:
Vaginitis
Communicable Diseases
Infection
Vaginal Diseases
Genital Diseases, Female
Clindamycin
Clindamycin-2-phosphate
Nystatin
Terconazole
Metronidazole
Fluocinolone Acetonide
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Radiation-Sensitizing Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
Ionophores
Membrane Transport Modulators

ClinicalTrials.gov processed this record on April 17, 2014