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Efficacy of Intravaginal Carboxymethyl-β-glucan and Polycarbophil on Low-grade Cervical Lesions (GLUCANCIN)

NCT04771546 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-06-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Colpofix

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

Sponsors & Collaborators

  • Hospital Universitario Infanta Leonor

    collaborator OTHER

  • Hospital Universitario 12 de Octubre

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Hospital Universitario Fundación Jiménez Díaz

    collaborator OTHER

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • Hospital Universitario La Paz

    collaborator OTHER

  • Uriach Consumer Healthcare

    lead INDUSTRY

Principal Investigators

  • Juan José Hernández Aguado, MD · Hospital Universitario Infanta Leonor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04771546 on ClinicalTrials.gov