Status:
UNKNOWN
Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ
Lead Sponsor:
University Medical Centre Maribor
Conditions:
Intraepithelial Neoplasia, Cervical
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Purpose: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with L...
Detailed Description
Imiquimod is one of the target topical drugs for treating HSIL. It is a Toll-like receptor 7 agonist that acts locally so that it induces cellular response, which can aid in the regression of HPV-asso...
Eligibility Criteria
Inclusion
- newly diagnosed and previously untreated HSIL in women aged 18 to 35 years or up to 40 years in case of nulliparity;
- satisfactory colposcopy (i.e., fully visible lesion and transformation zone);
- negative pregnancy test;
- safe contraception;
- signed, informed consent.
Exclusion
- previously diagnosed HSIL or AIS;
- previous LLETZ or classical conisation;
- concomitant vulvar or vaginal lesion or neoplasia;
- other malignancies;
- insufficient colposcopy;
- pregnancy or lactation;
- known hypersensitivity to imiquimod;
- any known contraindications to immunotherapy;
- known HIV or acute or chronic hepatitis;
- immune deficiency;
- participation in any other ongoing clinical trial.
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04859361
Start Date
November 20 2018
End Date
September 15 2023
Last Update
May 3 2021
Active Locations (1)
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1
University Medical Centre Maribor
Maribor, Slovenia, 2000