Trials Sponsors Conditions Drugs Pricing

Conditions

Infectious Vaginosis Vaginitis

Keywords

VaginitisInfectious vaginosisTerconazoleClindamycinFluocinoloneMetronidazoleNystatin

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 VDrug

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 VDrug

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.

Eligibility Criteria

Age18 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Janssen-Cilag, S.A.
Industrylead

Study Sites (2)

DF, Mexico City, Mexico

Mexico City, Mexico

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title: Clinical Research Director
Organization: Global Clinical Operations Mexico

Study Officials

Janssen-Cilag S.A. Clinical Trial
Janssen-Cilag, S.A.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

160 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Gynoclin V

Vagitrol V

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Gynoclin V

Vagitrol V

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations