Trial Outcomes & Findings for Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions (NCT NCT00566579)

Last Updated: 2010-08-10

Results Overview

At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.

Recruitment status

TERMINATED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 months

Results posted on

2010-08-10

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	29	31
Overall Study COMPLETED	29	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryotherapy n=29 Participants 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 n=31 Participants Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=99 Participants	31 Participants n=107 Participants	60 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age Continuous	42.17 years STANDARD_DEVIATION 7.86 • n=99 Participants	40.71 years STANDARD_DEVIATION 7.51 • n=107 Participants	41.42 years STANDARD_DEVIATION 7.65 • n=206 Participants
Sex: Female, Male Female	29 Participants n=99 Participants	31 Participants n=107 Participants	60 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Thailand	29 participants n=99 Participants	31 participants n=107 Participants	60 participants n=206 Participants

PRIMARY outcome

Timeframe: 12 months

At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.

Outcome measures

Outcome measures
Measure	Cryotherapy n=29 Participants 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 n=31 Participants Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
Number of Patients With Human Papillomavirus Clearance	26 participants	28 participants

Adverse Events

Cryotherapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Observation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cryotherapy n=29 participants at risk 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 n=31 participants at risk Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
Reproductive system and breast disorders HSIL	3.4% 1/29 • Number of events 1	6.5% 2/31 • Number of events 2

Additional Information

Bandit Chumworathayi

Department of OBGYN, Faculty of Medicine, Khon Kaen University, 40002, THAILAND

Phone: 66818733327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place