Who is sponsoring NCT01826045?

NCT01826045 is sponsored by BioLeaders Corporation.

What drugs are being tested in NCT01826045?

Interventions in NCT01826045: Poly-gamma Glutamic Acid, Placebo.

What condition does NCT01826045 study?

NCT01826045 studies Cervical Intraepithelial Neoplasia.

Is NCT01826045 still recruiting?

NCT01826045 is currently completed. Last updated 28 January 2016.

Last reviewed 2016-01-28 · How we verify

NCT01826045: PGA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 2 Last updated 28 January 2016

What this trial tests

Phase 2 trial testing Poly-gamma Glutamic Acid in Cervical Intraepithelial Neoplasia in 200 participants. Completed in 1 January 2016.

Timeline

1 June 2013

Primary endpoint
1 December 2015

1 January 2016

Quick facts

Lead sponsor	BioLeaders Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	200
Start date	1 June 2013
Primary completion	1 December 2015
Estimated completion	1 January 2016
Sites	7 locations across South Korea

Drugs / interventions tested

Poly-gamma Glutamic Acid — full drug profile →
Placebo

Conditions studied

Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →

Sponsor

BioLeaders Corporation — full company profile →

Who can join

Adults 20 to 49, female only, with Cervical Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Short-term clinical and immunologic effects of poly-gamma-glutamic acid (γ-PGA) in women with cervical intraepithelial neoplasia 1 (CIN 1): A multicenter, randomized, double blind, phase II trial.
Cho HW, Park YC, Sung MH, Park JS, et al · · 2019 · cited 10× · PMID 31220105 · DOI 10.1371/journal.pone.0217745

Verify or expand the search:

Other recruiting trials for Cervical Intraepithelial Neoplasia

Currently open trials in the same condition.

NCT07275333 — Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine · NA · recruiting
NCT06815939 — Validation of a Lab-free Low-cost Screening Test for Prevention of Cervical Cancer · NA · recruiting
NCT06810427 — A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings · NA · active not recruiting
NCT06191133 — Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma · Phase 1 · recruiting
NCT06243666 — Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls · active not recruiting

Other BioLeaders Corporation trials

Trials by the same sponsor.

NCT03789734 — Safety Study of BLS-M22 in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01826045 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioLeaders Corporation
Last refreshed: 28 January 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01826045.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing