A Multi-center, Randomized, Double Blind, Placebo Control, Parallel Design, Phase 2a Trial to Evaluate the Efficacy and Safety of PGA (Poly-gamma Glutamic Acid) for the Fertile Women With Cervical Intraepithelial Neoplasia 1 (CIN1)
This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1)
between the treatment group and the control group.
The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks
followed by 8 weeks observation.
The control group will be observed for 12 weeks without any comparator.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.
up to 12 weeks
Jae-Kwan Lee, MD, PhD
Korea University Guro Hospital
Korea: Food and Drug Administration