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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01571141
Enrollment
Unknown
Registered
2012-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HPV Infection

Keywords

HPV, polyhexamethylene biguanide, intraepithelial lesions, regression rate

Brief 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.

Interventions

DEVICEMonogin

Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Sponsors

AGUNCO Obstetrics and Gynecology Centre
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* pathologic Pap smear * positive high risk HPV DNA test * positive colposcopy examination

Exclusion criteria

* patients who had undergone wart therapy in the previous six months * pregnancy * invasive disease * immunosuppression * previous HPV vaccination

Design outcomes

Primary

MeasureTime frame
Number of patients with no HPV infection

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026