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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571141
First Posted: April 5, 2012
Last Update Posted: April 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
  Purpose

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.


Condition Intervention Phase
HPV Infection Device: Monogin Phase 4

Study Type: Interventional

Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • Number of patients with no HPV infection

Arms Assigned Interventions
Experimental: Monogin Device: Monogin
Gynaecological solution with polyhexamethylene biguanide, pH 4.0
No Intervention: No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571141


Locations
Italy
Consultorio Familiare Terme Vigliatore, A.S.P. 5
Messina, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01571141     History of Changes
Other Study ID Numbers: PHMB_HPV
First Submitted: April 2, 2012
First Posted: April 5, 2012
Last Update Posted: April 19, 2012
Last Verified: June 2011

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
HPV
polyhexamethylene biguanide
intraepithelial lesions
regression rate

Additional relevant MeSH terms:
Infection
Biguanides
Polihexanide
Hypoglycemic Agents
Physiological Effects of Drugs
Disinfectants
Anti-Infective Agents