Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions (Cryotherapy)
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ClinicalTrials.gov Identifier: NCT00566579 |
Recruitment Status :
Terminated
(Lack of additional funding)
First Posted : December 3, 2007
Results First Posted : August 2, 2010
Last Update Posted : August 10, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Papillomavirus Clearance at 12 Months | Procedure: Cryotherapy | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions: a Randomized Controlled Trial |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: A
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.
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Procedure: Cryotherapy
Double freezing technique
Other Name: Cryosurgery |
No Intervention: B
Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
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- Number of Patients With Human Papillomavirus Clearance [ Time Frame: 12 months ]At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.

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Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Biopsy-confirmed LSIL patients
- Age more than 30 years-old
- Baseline HPV testing is positive.
- Be able to give their informed consent to this study.
Exclusion Criteria:
- Having active cervical infection
- Having lesion of 2 mm-larger than probe
- Having lesion inside cervical os
- Having suspected cervical cancer lesion

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566579
Thailand | |
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University | |
Muang, Khon Kaen, Thailand, 40002 |
Principal Investigator: | Bandit Chumworathayi, MD | Gynecologic Oncology Division, OBGYN Department, Faculty of Medicine, Khon Kaen University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Clinical Epidemiology Unit (CEU), Faculty of Medicine, Khon Kaen University, Thailand |
ClinicalTrials.gov Identifier: | NCT00566579 |
Other Study ID Numbers: |
HE500830 |
First Posted: | December 3, 2007 Key Record Dates |
Results First Posted: | August 2, 2010 |
Last Update Posted: | August 10, 2010 |
Last Verified: | December 2007 |
Human papillomavirus Clearance Cryotherapy |
Squamous Intraepithelial Lesions of the Cervix Uterine Cervical Dysplasia Precancerous Conditions |
Neoplasms Uterine Cervical Diseases Uterine Diseases |