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Safety and Equivalence of a Terconazole Vaginal Suppository (Test Product) Compared to the Reference Terconazole Vaginal Suppository in the Treatment of Vulvovaginal Candidiasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT00803738
First received: December 5, 2008
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
Results First Received: May 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Vulvovaginal Candidiasis
Interventions: Drug: Terconazole Vaginal Suppository
Drug: Terazol Vaginal Suppository

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at 31 dermatology clinical practices.

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
Terconazole Vaginal Suppositories, 80 mg - Perrigo Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
Terazol 3 - Terconazole Vaginal Suppositories 80 mg Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days

Participant Flow:   Overall Study
    Terconazole Vaginal Suppositories, 80 mg - Perrigo     Terazol 3 - Terconazole Vaginal Suppositories 80 mg  
STARTED     286     286  
COMPLETED     192     176  
NOT COMPLETED     94     110  
Adverse Event                 3                 5  
Lost to Follow-up                 4                 4  
Protocol Violation                 18                 10  
Withdrawal by Subject                 1                 4  
Lack of Efficacy                 10                 16  
Negative Baseline Culture of Candida                 56                 63  
Positive Results for STD or abnormal PAP                 2                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Terconazole Vaginal Suppositories, 80 mg - Perrigo Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
Terazol 3 - Terconazole Vaginal Suppositories 80 mg Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
Total Total of all reporting groups

Baseline Measures
    Terconazole Vaginal Suppositories, 80 mg - Perrigo     Terazol 3 - Terconazole Vaginal Suppositories 80 mg     Total  
Number of Participants  
[units: participants]
 		  286     286     572  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     278     276     554  
>=65 years     8     10     18  
Age  
[units: years]
Mean ± Standard Deviation 		  33.4  ± 13.3     31.6  ± 13.1     32.5  ± 13.2  
Gender  
[units: participants]
 		     
Female     286     286     572  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     286     286     572  



  Outcome Measures
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1.  Primary:   Proportion of Subjects in Each Treatment Group With Therapeutic Cure   [ Time Frame: Visit 3: Day 22-31 ]
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2.  Secondary:   Proportion of Subjects With Mycological Cure   [ Time Frame: Visit 3: Day 22-31 ]
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3.  Secondary:   Proportion of Subjects With Clinical Cure   [ Time Frame: Visit 3: Day 22-31 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Jonathan Schwartz
Organization: Perrigo Pharmaceuticals
phone: 718-960-0119
e-mail: jonathan.schwartz@perrigo.com


No publications provided


Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT00803738     History of Changes
Other Study ID Numbers: CPL-202
Study First Received: December 5, 2008
Results First Received: May 11, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration