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Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia

NCT01826045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-01-29

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DRUG

Poly-gamma Glutamic Acid

DRUG

Placebo

Sponsors & Collaborators

  • BioLeaders Corporation

    lead INDUSTRY

Principal Investigators

  • Jae-Kwan Lee, MD, PhD · Korea University Guro Hospital

  • Tae Jin Kim, MD, PhD · Kwandong University College of Medicine Cheil Hospital

  • Jong Sup Park, MD, PhD · The Catholic University, Korea Seoul St Mary's Hospital

  • Chi-Heum Cho, MD, PhD · The Dongsan Medical Center of Keimyung University

  • Seok Ju Seong, MD, PhD · CHA University

  • Yongsoo Park, MD, PhD · MizMedi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01826045 on ClinicalTrials.gov