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Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection

NCT01571141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-04-19

No results posted yet for this study

Summary

Human papillomavirus (HPV) infection is a worldwide problem strictly linked to the development of cervical cancer. Persistence of the infection is one of the main factors responsible for the invasive progression and women diagnosed with intraepithelial squamous lesions are referred for further assessment and surgical treatments which are prone to complications. Despite this, there are several reports on the spontaneous regression of the infection.

In this study the investigators will evaluate the effectiveness of a long term polyhexamethylene biguanide (PHMB)-based local treatment in improve the viral clearance reducing the time exposure to the infection and avoiding the complications associated with the invasive treatments currently available.

Women diagnosed with HPV infection were randomly assigned to receive six months of treatment with a PHMB-based gynaecological solution (Monogin®) or to remain untreated for the same period of time.

The administration of Monogin® has been performed every three days for fifteen days and then every fifteen days for the subsequent six months.

Conditions

Interventions

DEVICE

Monogin

Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Sponsors & Collaborators

  • AGUNCO Obstetrics and Gynecology Centre

    lead OTHER

Eligibility

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

Timeline & Regulatory

Countries

  • Italy

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 NCT01571141 on ClinicalTrials.gov