Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01571141
Other study ID # PHMB_HPV
Secondary ID
Status Completed
Phase Phase 4
First received April 2, 2012
Last updated April 18, 2012

Study information

Verified date June 2011
Source AGUNCO Obstetrics and Gynecology Centre
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 45 Years
Eligibility 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

N/A


Related Conditions & MeSH terms


Intervention

Device:
Monogin
Gynaecological solution with polyhexamethylene biguanide, pH 4.0

Locations

Country Name City State
Italy Consultorio Familiare Terme Vigliatore, A.S.P. 5 Messina

Sponsors (1)

Lead Sponsor Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. doi: 10.1159/000318264. Epub 2010 Sep 8. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with no HPV infection
See also
  Status Clinical Trial Phase
Recruiting NCT04098744 - Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) Phase 2
Completed NCT04083196 - A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years Phase 1
Completed NCT04191967 - Thermocoagulation for Treatment of Precancerous Cervical Lesions N/A
Withdrawn NCT04430907 - HPV Vaccine in Postpartum Women
Recruiting NCT02593968 - Yallaferon in Chinese Population Phase 2
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Completed NCT02263378 - A New Supplement for the Immune Response to HPV Infection N/A
Completed NCT05234112 - Prevention and Screening Towards Elimination of Cervical Cancer N/A
Completed NCT04590521 - HPV Vaccine Immunity in High-risk Women Phase 4
Recruiting NCT05829629 - Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women Phase 1
Recruiting NCT06052033 - Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection N/A
Recruiting NCT05051852 - HPV Viral Load in Predicting the Prognosis of LSIL
Completed NCT04155294 - Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Active, not recruiting NCT06452004 - Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC) N/A
Completed NCT06177236 - Clinic or Self-Sampling for Cervical Cancer Screening N/A
Active, not recruiting NCT04794660 - The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa" Phase 3
Recruiting NCT05509413 - DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections N/A
Recruiting NCT06137950 - Interferon Alpha Therapy for Cervical CINI and HPV Infection Phase 1
Recruiting NCT04171505 - Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
Active, not recruiting NCT05524025 - The SPOT-HPV Study