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Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions

This study has been terminated.
(Lack of additional funding)
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00566579
First received: November 30, 2007
Last updated: August 2, 2010
Last verified: December 2007
Results First Received: June 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Human Papillomavirus Clearance at 12 Months
Intervention: Procedure: Cryotherapy

  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
During December 2007 to March 2009, 103 subjects who had been documented as LSIL from cervical biopsy histopathology were recruited from three colposcopic clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 of them declined to participate in this study. Only 60 of these 100 cases had positive results for HPV testing. Among women who had positive HPV testing results, 29 were randomly allocated to receive cryotherapy and 31 were allocated to observation.

Reporting Groups
  Description
Cryotherapy Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
Observation Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.

Participant Flow:   Overall Study
    Cryotherapy     Observation  
STARTED     29     31  
COMPLETED     29     31  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Cryotherapy Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
Observation Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
Total Total of all reporting groups

Baseline Measures
    Cryotherapy     Observation     Total  
Number of Participants  
[units: participants]
  29     31     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     29     31     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.17  ± 7.86     40.71  ± 7.51     41.42  ± 7.65  
Gender  
[units: participants]
     
Female     29     31     60  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Thailand     29     31     60  



  Outcome Measures

1.  Primary:   Number of Patients With Human Papillomavirus Clearance   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bandit Chumworathayi
Organization: Department of OBGYN, Faculty of Medicine, Khon Kaen University, 40002, THAILAND
phone: 66818733327
e-mail: bunchu@kku.ac.th


No publications provided by Khon Kaen University

Publications automatically indexed to this study:

Responsible Party: Clinical Epidemiology Unit (CEU), Faculty of Medicine, Khon Kaen University, Thailand
ClinicalTrials.gov Identifier: NCT00566579     History of Changes
Other Study ID Numbers: HE500830
Study First Received: November 30, 2007
Results First Received: June 1, 2010
Last Updated: August 2, 2010
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research