UnknownNot Applicable

Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.

South Korea50 participantsStarted 2017-05-30

Plain-language summary

This is a study to investigate the safety and efficacy of GX-188E administered IM plus local administration of GX-I7 or Imiquimod at cervix in subjects with cervical intraepithelial neoplasia (CIN) 3.

Who can participate

Age range

19 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able and willing to comply with all study procedures and voluntarily signs informed consent form. * Female subjects age 19-50 years. * HPV 16 and/or 18 positive. * Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area * Histopathologically diagnosed with Cervical Intraepithelial Neoplasia 3, CIN 3. Exclusion Criteria: * Pregnancy or breastfeeding * History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines are not excluded). * Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV). * Any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ratio of subjects who have histopathological regression of cervical lesions to CIN 1 or less in HPV 16 or 18-associated CIN3 subjects.

Timeframe: at week 20

Trial details

NCT IDNCT03206138

SponsorSeoul St. Mary's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10

Contact for this trial

Jong-Sup Park

+82-2-2258-2724 jspark@catholic.ac.kr

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia 3 trials