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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Measure Type	Primary
Measure Title	Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to CIN2, 3, CIS or Invasive Cancer
Measure Description	No text entered.
Time Frame	4 months
Safety Issue	No

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.
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Reporting Groups

	Description
Polyphenon E	No text entered.
Placebo	No text entered.

Measured Values

	Polyphenon E	Placebo
Number of Participants Analyzed [units: participants]	41	41
Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to CIN2, 3, CIS or Invasive Cancer [units: participants]	6	3

No statistical analysis provided for Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to CIN2, 3, CIS or Invasive Cancer

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 from the time submitted to the sponsor for review. The sponsor may require changes to the communication.

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: H-H. Sherry Chow, Ph.D.
Organization: The University of Arizona
phone: 520-626-3358
e-mail: schow@azcc.arizona.edu

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00303823 History of Changes
Other Study ID Numbers:	CDR0000458081, UARIZ-UAZ03-1-02, UARIZ-HSC-0540
Study First Received:	March 15, 2006
Results First Received:	July 13, 2012
Last Updated:	July 13, 2012
Health Authority:	United States: Food and Drug Administration

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