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A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Perrigo Company
ClinicalTrials.gov Identifier:
NCT01039584
First received: December 23, 2009
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
Results First Received: September 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: Vulvovaginal Candidiasis
Interventions: Drug: Butoconazole Nitrate Vaginal Cream
Drug: Placebo
Drug: Gynazole 1 vaginal cream

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Test Product

Butoconazole Nitrate Vaginal Cream

Butoconazole Nitrate Vaginal Cream : vaginal cream
Reference Product

Gynazole 1 Vaginal Cream

Gynazole 1 vaginal cream : vaginal cream
Placebo

vehicle of the test product

Placebo : vaginal cream

Participant Flow:   Overall Study
    Test Product     Reference Product     Placebo  
STARTED     246     243     122  
COMPLETED     143     146     65  
NOT COMPLETED     103     97     57  
Withdrawal by Subject                 4                 2                 1  
Protocol Violation                 10                 4                 6  
Lost to Follow-up                 5                 3                 4  
Negative Baseline culture for Candida                 59                 59                 24  
Lack of Efficacy                 7                 6                 10  
other                 1                 3                 1  
Pap smear with significant pathology                 10                 10                 3  
Positive for Chlamydia or gonorrhea                 7                 10                 8  



  Baseline Characteristics
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Reporting Groups
  Description
Test Product

Butoconazole Nitrate Vaginal Cream

Butoconazole Nitrate Vaginal Cream : vaginal cream
Reference Product

Gynazole 1 Vaginal Cream

Gynazole 1 vaginal cream : vaginal cream
Placebo

vehicle of the test product

Placebo : vaginal cream
Total Total of all reporting groups

Baseline Measures
    Test Product     Reference Product     Placebo     Total  
Number of Participants  
[units: participants]
 		  246     243     122     611  
Age  
[units: participants]
 		       
<=18 years     8     5     4     17  
Between 18 and 65 years     236     238     117     591  
>=65 years     2     0     1     3  
Age  
[units: years]
Mean ± Standard Deviation 		  32.1  ± 10.29     32.1  ± 10.02     33.3  ± 11.15     32.3  ± 10.35  
Gender  
[units: participants]
 		       
Female     246     243     122     611  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     108     107     54     269  
Central America     54     53     26     133  
South America     84     83     42     209  



  Outcome Measures
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1.  Primary:   The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.   [ Time Frame: Visit 3: Day 22-31 ]
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2.  Secondary:   Clinical Cure   [ Time Frame: Visit 3: Day 22-31 ]
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3.  Secondary:   Mycological Cure   [ Time Frame: Visit 3: Day 22-31 ]
  Show Outcome Measure 3


  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
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Results Point of Contact:  
Name/Title: Jonathan Schwartz
Organization: Perrigo
phone: 718-960-9900
e-mail: jonathan.schwartz@perrigo.com


No publications provided


Responsible Party: Perrigo Company
ClinicalTrials.gov Identifier: NCT01039584     History of Changes
Other Study ID Numbers: PRG-710
Study First Received: December 23, 2009
Results First Received: September 10, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board