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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 2, 2012
Last Updated Date	April 18, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 3, 2012)	Number of patients with no HPV infection
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01571141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	HPV Infection
Intervention ^ICMJE	Device: Monogin Gynaecological solution with polyhexamethylene biguanide, pH 4.0
Study Arm (s)	Experimental: Monogin Intervention: Device: Monogin No Intervention: No intervention
Publications *	Zanotti KM, Belinson J. Update on the diagnosis and treatment of human papillomavirus infection. Cleve Clin J Med. 2002 Dec;69(12):948, 951-5, 956 passim. Review. Hübner NO, Kramer A. Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic. Skin Pharmacol Physiol. 2010;23 Suppl:17-27. Epub 2010 Sep 8. Review. Marelli G, Papaleo E, Origoni M, Caputo L, Ferrari A. Polyhexamethylene biguanide for treatment of external genital warts: a prospective, double-blind, randomized study. Eur Rev Med Pharmacol Sci. 2005 Nov-Dec;9(6):369-72.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	30 Years to 45 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01571141
Other Study ID Numbers ^ICMJE	PHMB_HPV
Has Data Monitoring Committee	No
Responsible Party	AGUNCO Obstetrics and Gynecology Centre
Study Sponsor ^ICMJE	AGUNCO Obstetrics and Gynecology Centre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AGUNCO Obstetrics and Gynecology Centre
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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