NCT04771546

Brief Summary

A therapeutic strategy to neutralize the evasion mechanisms of HPV. Among these treatments are beta-glucans, polysaccharides of beta-D-glucose that, can influence the clearance of HPV. The objective of this study is to evaluate the efficacy of a gel with Carboxymethyl - β -Glucan and polycarbophil when applied intravaginally, on the regression of low-grade cervical intraepithelial lesions (CIN) associated to HR-HPV infection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

February 22, 2021

Last Update Submit

June 11, 2021

Conditions

Human Papilloma Virus

Keywords

Human PapilomavirusCervical cancerLow-grade Cervial intraepithelial lesionsHigh-Risk PapillomavirusCIN1beta-glucans

Outcome Measures

Primary Outcomes (1)

  • Change in CIN1 regression rate

    CIN evaluation by biopsy

    24 months (6, 12, 18 and 24 months)

Secondary Outcomes (8)

  • CIN1 lesion regression or clearance time

    24 months (6, 12, 18 and 24 months)

  • Progression to CIN2+ rate

    24 months (6, 12, 18 and 24 months)

  • HPV clearance rate

    24 months (6, 12, 18 and 24 months)

  • HPV clearance time

    24 months (6, 12, 18 and 24 months)

  • Normalization rate of abnormal cytology

    24 months (6, 12, 18 and 24 months)

  • +3 more secondary outcomes

Study Arms (2)

Intervention (Colpofix)

EXPERIMENTAL

Intravaginal gel with Carboxymethyl-β-glucan and Polycarbophil

Device: Colpofix

Control

NO INTERVENTION

No intervention (standard of care)

Interventions

ColpofixDEVICE

Intravaginal gel with carboxymtheyl beta-glucan and polycabophil. Posology: 1 application / day x 20 days, rest 10. Repeat 20 x 3 cycles

Intervention (Colpofix)

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Woman between 30 and 50 years old
  • Capable of understanding the Pacient Information Sheet and the Informed Consent form
  • Accepting her particpation in the study and signing the Informed Consent
  • LSIL/CIN1 hystological result on cervical biopsy preceeded by HR-HPV+ test (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
  • Cervical cytology ≥ ASCUS or precceded by a HPV16+ test and negative cervical cytology for lesion or malignancy but with CIN1 colposcopy and biopsy.

You may not qualify if:

  • Cervical cytology suspicious of invasive cervical cancer
  • Current or previous pregnancy ended before six weeks in relation to the start of the study.
  • Vaccination against HPV.
  • Clinically relevant pathology linked to immunodeficiency.
  • Undiagnosed abnormal genital bleeding.
  • Total hysterectomy.
  • Presence of genital warts and other symptomatic vulvovaginal infections.
  • Documented history of cervical pathology caused by HPV.
  • Current systemic and / or gynecological disease that contraindicates the use of Colpofix.
  • Contraindications to the use of Colpofix or known allergies to any of its components
  • Simultaneous participating in a clinical study of an investigational drug or that could interfere with the use of Colpofix.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitario Infanta Leonor

Vallecas, Madrid, 28031, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (7)

  • Geller A, Shrestha R, Yan J. Yeast-Derived beta-Glucan in Cancer: Novel Uses of a Traditional Therapeutic. Int J Mol Sci. 2019 Jul 24;20(15):3618. doi: 10.3390/ijms20153618.

    PMID: 31344853BACKGROUND

  • Chaichian S, Moazzami B, Sadoughi F, Haddad Kashani H, Zaroudi M, Asemi Z. Functional activities of beta-glucans in the prevention or treatment of cervical cancer. J Ovarian Res. 2020 Mar 5;13(1):24. doi: 10.1186/s13048-020-00626-7.

    PMID: 32138756BACKGROUND

  • Stentella P, Biamonti A, Carraro C, Inghirami P, Mancino P, Pietrangeli D, Votano S, Lazzari P, DE Medici C. Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study. Minerva Ginecol. 2017 Oct;69(5):425-430. doi: 10.23736/S0026-4784.17.04053-9.

    PMID: 28675291BACKGROUND

  • Pietrantoni E, Signore F, Berardi G, Donadio F, Donadio C. [Role of beta-glucan in the treatment of recurrent candidiasis and HPV-correlated lesions and reparative process of epidermis]. Minerva Ginecol. 2010 Feb;62(1):1-5. Italian.

    PMID: 20186110BACKGROUND

  • Scardamaglia P, Carraro C, Mancino P, Stentella P. [Effectiveness of the treatment with beta-glucan in the HPV-CIN 1 lesions]. Minerva Ginecol. 2010 Oct;62(5):389-93. Italian.

    PMID: 20938424BACKGROUND

  • Palmeira-de-Oliveira R, Palmeira-de-Oliveira A, Martinez-de-Oliveira J. New strategies for local treatment of vaginal infections. Adv Drug Deliv Rev. 2015 Sep 15;92:105-22. doi: 10.1016/j.addr.2015.06.008. Epub 2015 Jul 2.

    PMID: 26144995BACKGROUND

  • Fiorilli A, Molteni B, Milani M. Successful treatment of bacterial vaginosis with a policarbophil-carbopol acidic vaginal gel: results from a randomised double-blind, placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2005 Jun 1;120(2):202-5. doi: 10.1016/j.ejogrb.2004.10.011.

    PMID: 15925053BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Juan José Hernández Aguado, MD

    Hospital Universitario Infanta Leonor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan José Hernández Aguado, MD

CONTACT

+34619246280jjhernandeza@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Interventional, longitudinal, prospective, open label trial with a control group with randomized, consecutive recruitment for each group, to evaluate the safety and efficacy of carboxymethyl-beta-glucan and polycarbophil as a treatment for low-grade CIN associatedto HR-HPV infection.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

June 15, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(5)