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

Phase 4

Completed

• Conditions: HPV Infection
• Interventions: Device: Monogin

• Registration Number: NCT01571141
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-06
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-05
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monogin	Monogin	-

Primary Outcome Measures

Name	Time	Method
Number of patients with no HPV infection

Trial Locations

Locations (1)

Consultorio Familiare Terme Vigliatore, A.S.P. 5; 🇮🇹 Messina, Italy