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Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00303823
First received: March 15, 2006
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
Results First Received: July 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Cervical Cancer
Precancerous Condition
Interventions: Drug: defined green tea catechin extract
Other: placebo

  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
Polyphenon E No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Polyphenon E     Placebo  
STARTED     50     48  
COMPLETED     35     38  
NOT COMPLETED     15     10  



  Baseline Characteristics
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Reporting Groups
  Description
Polyphenon E No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Polyphenon E     Placebo     Total  
Number of Participants  
[units: participants]
 		  50     48     98  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     50     48     98  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  28.48  ± 8.78     28.27  ± 8.05     28.28  ± 8.39  
Gender  
[units: participants]
 		     
Female     50     48     98  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     50     48     98  



  Outcome Measures
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1.  Primary:   Complete Response - Clearance of Oncogenic HPV and Complete Colposcopic, Histologic and Cytologic Clearance of Disease   [ Time Frame: 4 months ]
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2.  Primary:   Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]
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3.  Primary:   No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia   [ Time Frame: 4 months ]
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4.  Primary:   Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to CIN2, 3, CIS or Invasive Cancer   [ Time Frame: 4 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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