Cervical Intraepithelial Neoplasia 2 (CIN2)
Conditions
Interventions
The CIN therapeutic vaccine or placebo will be taken in 20 days (1st~5th, 8th~12th, 22nd~26th and 50th~54th day) within all administering period (8 weeks). The dosage is assumed to be 4 capsules/time/
Sponsors
The University of Tokyo Hospital Department of Obstetrics & Gynecology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) HPV16 infected women 2) whom can observe all lesioned part by colposcopic inspection 3) patients were diagnosed with CIN2 histologically and judged that follow-up is necessary 4) whom of 20 ~ 50 years old when agreement is acquired. 5) outpatient 6) All patients were required to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Person who has obviously received prohibition of using together medicine (treatment) that causes person and immune suppression that has disease that abnormality is found in immune function 2) patients of SCC in cervical cytology. 3) whom hope for laser ablation or conization of the cervix 4) patients with serious acute illness 5) patients that there are previous histories of hypersensitivity in lactobacillus content food (yogurt etc.) and preparation of lactobacillus 6) patients who has allergy for milk 7) pregnant or expected to be pregnant 8) breast feeding mother 9) whom administered other trial drugs within three months before initiation of this trial study 10) whom administered this medicine 11) whom the investigator think inappropriate as a candidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy and safety | — |
Countries
Japan
Contacts
Public ContactKei Kawana
The University of Tokyo Hospital Department of Obstetrics & Gynecology
Outcome results
None listed