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Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)

NCT07735039 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Human Papillomavirus Infection
  • Cervical Intraepithelial Neoplasia (CIN)
  • Low-Grade Squamous Intraepithelial Lesions

Interventions

DRUG

Oral Immunomodulator

Oral immunomodulator administered twice daily for 3 months.

DRUG

Vaginal Ovule

Vaginal ovule administered for 14 consecutive days each month for 3 months.

OTHER

Standard Supportive Care

Standard supportive care according to routine clinical practice during the 3-month study period.

Sponsors & Collaborators

  • Dr. Lutfi Kirdar Kartal Training and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-28
Primary Completion
2026-08-23
Completion
2026-08-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735039 on ClinicalTrials.gov