Status:
RECRUITING
Effect of Honey For CIN II
Lead Sponsor:
Zuyderland Medisch Centrum
Conditions:
Cervical Intraepithelial Neoplasia-II
High Risk Human Papillomavirus
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
Brief Summary
The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.
Detailed Description
In this pilot study, we will include 60 patients with newly diagnosed CIN II. Patients will be counseled according to standard guidelines between a LLETZ, imiquimod or expectant management. Patients c...
Eligibility Criteria
Inclusion
- Women 18-40 years
- Primary CIN II confirmed histologically in the biopsy on colposcopic examination
- Sufficient mastery of the Dutch language
Exclusion
- Simultaneous abnormality in columnar epithelial cells (AIS).
- Hr-HPV negative cytology
- Immunosuppressant use/Autoimmune disease (HIV, CVID)
- History of cervical carcinoma or previous treatment for CIN (LLETZ or imiquimod)
- Pregnancy or the intention to become pregnant during the study period
- Legal incompetence
- Known allergies to honey
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06219018
Start Date
December 30 2024
End Date
December 1 2027
Last Update
June 18 2025
Active Locations (2)
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1
Zuyderland MC
Heerlen, Limburg, Netherlands, 6149 PC
2
Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands, 6229 HX