MedTrace Logo

Interferon Alpha Therapy for Cervical CINI and HPV Infection

NCT06137950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-03

No results posted yet for this study

Summary

Mongolia is a traditionally nomadic and population is scarce in rural areas. Thus, the medical care service is not sufficient. In 2000, Mongolian government has developed and implemented the millennium project in cooperation with WHO. During the years pap smear analysis of implemented in all rural areas and clinicians, lab technicians have been taught for the cervical cancer screening. However, the project has finished in 2015 and the rural and district hospitals has lost the trained professionals. Still the cervical cancer is in second place after liver cancer in women.

The purpose of the study is to identify the type of HPV genotype and to treat the HPV infection by local interferon α2b.

Materials and methods: HPV positive patients will be enrolled to the study. HPV genotype will be determined by the PCR in laboratory. Pap smear will be taken and staged by the CIN. Pathological tissue will be taken under colposcopy with acetic acid test. Follow up visit will be done on 10th, 30th days of the treatment.

At the end of 90th days of treatment, pap and histology test will be repeated and CIN regression or viral eradication will be evaluated.

Conditions

Interventions

DRUG

gel Interferon arm

0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days.

DRUG

gel Interferon and interferon suppository arm

0.2 ml gel interferon will be administered into vaginal using 1 ml syringe with measurement line. Patients will be trained how to fill the syringe and put into the vagina. Gel will be administered 2 times per day during the non menstruating day totally for 28 days. 3MIU suppository will be given to patients and will be trained how to use. Each patient in the arm will use the suppository twice a day for 10 days with vaginal therapy.

Sponsors & Collaborators

  • Mongolian National Cancer Center

    collaborator UNKNOWN

  • Mongolian National University of Medical Sciences

    lead OTHER

Principal Investigators

  • Batsuren Choijamts, Ph.D · Mongolian National University of Medical Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-07
Primary Completion
2024-11-15
Completion
2025-03-31

Countries

  • Mongolia

Study Locations

More Related Trials

Entities

Diseases

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 NCT06137950 on ClinicalTrials.gov