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Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Summary
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.
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of a Dual-Modality Immunotherapy (Oral Immunomodulator and Vaginal Ovule) for Human Papillomavirus (HPV) Clearance
Key Details
Gender
FEMALE
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2026-04-28
Completion Date
2026-08-24
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Oral Immunomodulator
Oral immunomodulator administered twice daily for 3 months.
Vaginal Ovule
Vaginal ovule administered for 14 consecutive days each month for 3 months.
Standard Supportive Care
Standard supportive care according to routine clinical practice during the 3-month study period.
Locations (1)
University of Health Sciences Turkey, Kartal Dr. Lütfi Kırdar City Hospital
Istanbul, Istanbul, Turkey (Türkiye)