drugset / Trial / NCT01826045

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

NCT01826045 ↗

Phase 2 Completed 200 enrolled BioLeaders Corporation
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2013-06
Primary completion
2015-12
Completion
2016-01

Outcome

Met primary endpoint

paper 42 (42.4%) of the women who received γ-PGA experienced histologic remission versus 26 (27.1%) in the control group, with a statistically significant difference (p = 0.018). PMID 31220105 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Poly-gamma Glutamic Acid Unknown 1500 mg Oral