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| ID | Type | Description | Link |
|---|---|---|---|
| 12335 | Other Identifier | Korea Food and Drug Administration |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly-gamma Glutamic Acid | Experimental | Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks. |
|
| Placebo | Placebo Comparator | Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-gamma Glutamic Acid | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reid Colposcopic Index | Reid Colposcopic Index will be assessed at the time of screening and 12 weeks. | up to 12 weeks |
| Pap smear test | Result of Pap smear test will be assessed at the time of screening and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be monitored for 12 weeks. | up to 12 weeks |
| Vital Signs | Vital signs will be monitored for 12 weeks. | up to 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Kwan Lee, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Tae Jin Kim, MD, PhD | Kwandong University College of Medicine Cheil Hospital | Principal Investigator |
| Jong Sup Park, MD, PhD | The Catholic University, Korea Seoul St Mary's Hospital | Principal Investigator |
| Chi-Heum Cho, MD, PhD | The Dongsan Medical Center of Keimyung University | Principal Investigator |
| Seok Ju Seong, MD, PhD | CHA University | Principal Investigator |
| Yongsoo Park, MD, PhD | MizMedi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Seoul | 152-703 | South Korea | ||
| The Dongsan Medical Center of Keimyung Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31220105 | Derived | Cho HW, Park YC, Sung MH, Park JS, Kim TJ, Seong SJ, Cho CH, Lee JK. Short-term clinical and immunologic effects of poly-gamma-glutamic acid (gamma-PGA) in women with cervical intraepithelial neoplasia 1 (CIN 1): A multicenter, randomized, double blind, phase II trial. PLoS One. 2019 Jun 20;14(6):e0217745. doi: 10.1371/journal.pone.0217745. eCollection 2019. |
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|
| 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. | 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. | 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. | 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. | up to 12 weeks |
| Laboratory Tests | Result of laboratory tests will be assessed at screening. | up to 12 weeks |
| Daegu |
| 700-712 |
| South Korea |
| Kwandong University College of Medicine Cheil Hospital | Seoul | 100-380 | South Korea |
| CHA Gangnam Hospital | Seoul | 135-913 | South Korea |
| The Catholic University, Korea Seoul St Mary's Hospital | Seoul | 137-701 | South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| MiZMedi Hospital | Seoul | 157-723 | South Korea |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C511775 | poly(gamma-glutamic acid) |
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