RecruitingPhase 1Phase 2NCT06219018
Effect of Honey For CIN II
The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II
Sponsor
Zuyderland Medisch Centrum
Enrollment
60 participants
Start Date
Dec 30, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years
Inclusion Criteria3
- Women 18-40 years
- Primary CIN II confirmed histologically in the biopsy on colposcopic examination
- Sufficient mastery of the Dutch language
Exclusion Criteria7
- 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
Interventions
DRUGMedical grade honey formulation (MGH) (L-Mesitran®)
Daily application of 5 grams (with applicator) for the first 3 months, followed by weekly application of 5 grams for the following 3 months.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06219018