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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) 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.
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) 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.

Participant Flow:   Overall Study
    Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)   Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)
STARTED   81   79 
COMPLETED   81   79 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide) 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.
Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin) 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 Total of all reporting groups

Baseline Measures
   Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)   Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   79   160 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 30.69  (7.17)   30.56  (7.50)   30.63  (7.33) 
Gender 
[Units: Participants]
     
Female   81   79   160 
Male   0   0   0 


  Outcome Measures

1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Secondary:   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) ]

5.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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