NCT01571141

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: AGUNCO Obstetrics and Gynecology Centre · Academic / Other
• Sex: Female
• Age: 30 Years – 45 Years
• Healthy volunteers: Not accepted

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

• HPV Infection

Interventions

Type	Name	Description
DEVICE	Monogin	Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Timeline

• First posted: 2012-04-05
• Last updated: 2012-04-19

Locations

1 site across 1 country: Italy