Trials / Completed
CompletedNCT01826045
Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- BioLeaders Corporation · Industry
- Sex
- Female
- Age
- 20 Years – 49 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Poly-gamma Glutamic Acid | |
| DRUG | Placebo |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-12-01
- Completion
- 2016-01-01
- First posted
- 2013-04-08
- Last updated
- 2016-01-29
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01826045. Inclusion in this directory is not an endorsement.