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

NCT01867164 | Completed Phase 3 Results

• 2 other identifiers: CR100569TEROV8BAC4001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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).

Conditions

Vaginitis; Infectious Vaginosis

Keywords

Vaginitis; Infectious vaginosis; Terconazole; Clindamycin; Fluocinolone; Metronidazole; Nystatin

Outcome Measures

Primary Outcomes (3)

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

  Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.

  3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)

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

  Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.

  8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)

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

  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.

  3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Gynoclin V

EXPERIMENTAL

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

Vagitrol V

EXPERIMENTAL

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

Interventions

Gynoclin V DRUG

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.

Gynoclin V

Vagitrol V DRUG

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.

Vagitrol V

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participant with a known allergy to vaginal treatments
• Participant with suspected pregnancy or currently breastfeeding
• 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)

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

Study Sites (2)

Unknown Facility

DF, Mexico City, Mexico

Location

Unknown Facility

Mexico City, Mexico

Location

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Clinical Research Director
• Organization: Global Clinical Operations Mexico

+52 55 5484 3184

Study Officials

• Janssen-Cilag S.A. Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 3, 2013
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 24, 2013
• Results First Posted: December 24, 2013

Record last verified: 2013-11

Locations

ME (2)