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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Korea University Guro Hospital
Seoul, Seoul, South Korea
The Dongsan Medical Center of Keimyung Hospital
Daegu, South Korea
Kwandong University College of Medicine Cheil Hospital
Seoul, South Korea
CHA Gangnam Hospital
Seoul, South Korea
Regression rate
Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal.
Time frame: up to 12 weeks
Reid Colposcopic Index
Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
Time frame: up to 12 weeks
Pap smear test
Result of Pap smear test will be assessed at the time of screening and 12 weeks.
Time frame: up to 12 weeks
HPV (Human Papilloma Virus) DNA Test
Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.
Time frame: up to 12 weeks
HPV (Human Papilloma Virus) Hybrid CaptureII Test
Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks.
Time frame: up to 12 weeks
NK (Natural Killer) Cell Activity
Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
Time frame: up to 12 weeks
Peripheral Blood Mononuclear Cells (PBMCs)Test
Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks.
Time frame: up to 12 weeks
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The Catholic University, Korea Seoul St Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
MiZMedi Hospital
Seoul, South Korea