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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:

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.


Sponsor: BioLeaders Corporation

Current Primary Outcome: Regression rate [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reid Colposcopic Index [ Time Frame: up to 12 weeks ]
    Reid Colposcopic Index will be assessed at the time of screening and 12 weeks.
  • Pap smear test [ Time Frame: 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 [ Time Frame: up to 12 weeks ]
    Result of HPV (Human Papilloma Virus) DNA Test will be assessed at the time of screening and 12 weeks.
  • HPV (Human Papilloma Virus) Hybrid CaptureII Test [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: BioLeaders Corporation

Dates:
Date Received: March 29, 2013
Date Started: June 2013
Date Completion:
Last Updated: January 28, 2016
Last Verified: January 2016