Cervical Intraepithelial Neoplasia
Conditions
Keywords
Treatment of Cervical Intraepithelial Neoplasia(CIN1)
Brief 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).
Detailed description
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.
Interventions
DRUGPoly-gamma Glutamic Acid
DRUGPlacebo
Sponsors
BioLeaders Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Fertile women between age of 20 and 49 * Patients with cervical intraepithelial neoplasia 1(CIN1) * HPV(Human Papilloma Virus) positive(+) * White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10\^6/L * AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal * Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray * Be informed of the nature of the study and will give written informed consent
Exclusion criteria
* Malignant tumor in any organ other than cervical intraepithelial neoplasia * Active liver disease, immune disorder and severe renal failure * Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded) * Diagnosed diabetes * Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc) * Pregnancy and breastfeeding * Registered in other clinical trials * Patients whom the investigator considers inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression rate | up to 12 weeks | Regression rate will be assessed at the time of screening and 12 weeks. Regression means the change from the stage of CIN1 to normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reid Colposcopic Index | up to 12 weeks | Reid Colposcopic Index will be assessed at the time of screening and 12 weeks. |
| HPV (Human Papilloma Virus) Hybrid CaptureII Test | up to 12 weeks | Result of HPV (Human Papilloma Virus) Hybrid CaptureII Test will be assessed at the time of screening and 12 weeks. |
| NK (Natural Killer) Cell Activity | up to 12 weeks | Result of NK (Natural Killer) Cell Activity will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks. |
| Peripheral Blood Mononuclear Cells (PBMCs)Test | up to 12 weeks | Result of Peripheral Blood Mononuclear Cells (PBMCs) Test will be assessed at the time of baseline (0day), 4 weeks, 8 weeks and 12 weeks. |
| Pap smear test | up to 12 weeks | Result of Pap smear test will be assessed at the time of screening and 12 weeks. |
| HPV (Human Papilloma Virus) DNA Test | up to 12 weeks | Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Laboratory Tests | up to 12 weeks | Result of laboratory tests will be assessed at screening. |
| Adverse Events | up to 12 weeks | Adverse events will be monitored for 12 weeks. |
| Vital Signs | up to 12 weeks | Vital signs will be monitored for 12 weeks. |
Countries
South Korea
Outcome results
None listed