Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.
Inclusion Criteria:
Exclusion Criteria:
Outcome assessors evaluating HPV test and cervical cytology results are blinded to treatment allocation.
Participants receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months.
Participants receive standard supportive care for 3 months according to routine clinical practice.
Istanbul, Istanbul 34865, Turkey (Türkiye)
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