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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

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ClinicalTrials.gov Identifier: NCT01867164
Recruitment Status : Completed
First Posted : June 3, 2013
Results First Posted : December 24, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Vaginitis
Infectious Vaginosis
Interventions Drug: Gynoclin V
Drug: Vagitrol V
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days. One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
Period Title: Overall Study
Started 81 79
Completed 81 79
Not Completed 0 0
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) Total
Hide Arm/Group Description One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days. One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days. Total of all reporting groups
Overall Number of Baseline Participants 81 79 160
Hide Baseline Analysis Population Description
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population.
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 79 participants 160 participants
30.69  (7.17) 30.56  (7.50) 30.63  (7.33)
[1]
Measure Description: Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. A total of 81 participants in Gynoclin V and 78 participants in Vagitrol V were analyzed for this Baseline characteristic.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 79 participants 160 participants
Female
81
 100.0%
79
 100.0%
160
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment
Hide Description Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Time Frame 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure.
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description:
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
Overall Number of Participants Analyzed 79 77
Measure Type: Number
Unit of Measure: Percentage of Participants
Itching: Absent 67.1 79.2
Itching: Present 32.9 20.8
Burning: Absent 78.5 88.3
Burning: Present 21.5 11.7
Sudden vulvar pain: Absent 95.0 90.9
Sudden vulvar pain: Present 5.0 9.1
2.Primary Outcome
Title Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment
Hide Description Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.
Time Frame 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description:
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
Overall Number of Participants Analyzed 77 75
Measure Type: Number
Unit of Measure: Percentage of Participants
Itching: Absent 88.3 85.3
Itching: Present 11.7 14.7
Burning: Absent 93.5 92
Burning: Present 6.5 8
Sudden vulvar pain: Absent 97.4 89.3
Sudden vulvar pain: Present 2.6 10.7
3.Primary Outcome
Title Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment
Hide Description 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.
Time Frame 3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed.
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description:
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
Overall Number of Participants Analyzed 78 76
Measure Type: Number
Unit of Measure: Percentage of Participants
Candida albicans 2.5 0
Candida species, Gardnerella vaginalis 9.8 1.3
Vaginal Flora 55.6 58.2
Lactobacillus species 28.4 36.7
No culture performed 3.7 3.8
4.Secondary Outcome
Title Percentage of Participants With Response to Treatment Assessed by Participant
Hide Description 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).
Time Frame 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description:
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
Overall Number of Participants Analyzed 77 75
Measure Type: Number
Unit of Measure: Percentage of Participants
Poor 1.30 1.30
Moderate 0 4.00
Good 36.40 29.40
Excellent 62.30 65.30
5.Secondary Outcome
Title Percentage of Participants With Response to Treatment Assessed by Physician
Hide Description 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).
Time Frame 8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description:
One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
Overall Number of Participants Analyzed 77 75
Measure Type: Number
Unit of Measure: Percentage of Participants
Poor 1.30 1.30
Moderate 0 5.30
Good 28.60 26.70
Excellent 70.10 66.70
Time Frame Baseline up to Day 13 for Gynoclin V and Day 18 for Vagitrol V
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Hide Arm/Group Description One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days. One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
All-Cause Mortality
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/81 (0.00%)   0/79 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/81 (1.23%)   1/79 (1.27%) 
Infections and infestations     
Fungal Infections * 1  0/81 (0.00%)  1/79 (1.27%) 
Nervous system disorders     
Headache * 1  1/81 (1.23%)  0/79 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Research Director
Organization: Global Clinical Operations Mexico
Phone: +52 55 5484 3184
Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT01867164     History of Changes
Other Study ID Numbers: CR100569
TEROV8BAC4001
First Submitted: May 29, 2013
First Posted: June 3, 2013
Results First Submitted: July 12, 2013
Results First Posted: December 24, 2013
Last Update Posted: December 24, 2013