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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01571141
First received: April 2, 2012
Last updated: April 18, 2012
Last verified: June 2011

April 2, 2012
April 18, 2012
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Number of patients with no HPV infection
Same as current
Complete list of historical versions of study NCT01571141 on ClinicalTrials.gov Archive Site
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Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
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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.

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Interventional
Phase 4
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HPV Infection
Device: Monogin
Gynaecological solution with polyhexamethylene biguanide, pH 4.0
  • Experimental: Monogin
    Intervention: Device: Monogin
  • No Intervention: No intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Female
30 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01571141
PHMB_HPV
No
AGUNCO Obstetrics and Gynecology Centre
AGUNCO Obstetrics and Gynecology Centre
Not Provided
Not Provided
AGUNCO Obstetrics and Gynecology Centre
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP