HPV InfectionPhase 4NCT01571141
Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
A Phase 4 study testing Monogin in people with HPV Infection, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- Monogin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pathologic Pap smear
- positive "high risk" HPV DNA test
- positive colposcopy examination
Who cannot join
- patients who had undergone wart therapy in the previous six months
- pregnancy
- invasive disease
- immunosuppression
- previous HPV vaccination
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- HPV Infection
- Being tested
- Monogin
- Keywords
- HPV, polyhexamethylene biguanide, intraepithelial lesions, regression rate
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoginDevice
Gynaecological solution with polyhexamethylene biguanide, pH 4.0
| Study group | Role | What they receive |
|---|---|---|
| Monogin | Experimental | Not described Receives: Device: Monogin |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with no HPV infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571141
- Sponsor's protocol ID
- PHMB_HPV
- Status last verified
- Jun 2011
- First submitted
- 2 Apr 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.3949/ccjm.69.12.948.
PubMed 12546268Hubner 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.
PubMed 20829658Marelli 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.
PubMed 16479742Gentile A, Gerli S, Di Renzo GC. A new non-invasive approach based on polyhexamethylene biguanide increases the regression rate of HPV infection. BMC Clin Pathol. 2012 Sep 25;12:17. doi: 10.1186/1472-6890-12-17.
PubMed 23009652
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyhexamethylene Biguanide Increases the Regression Rate of Human Papillomavirus (HPV) Infection
- ClinicalTrials.gov ID
- NCT01571141
- Acronym / sponsor ID
- PHMB_HPV
- Conditions
- HPV Infection
- Keywords
- HPV, polyhexamethylene biguanide, intraepithelial lesions, regression rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monogin | Experimental | Device: Monogin |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pathologic Pap smear
- positive "high risk" HPV DNA test
- positive colposcopy examination
Key exclusion criteria (5 listed)
- patients who had undergone wart therapy in the previous six months
- pregnancy
- invasive disease
- immunosuppression
- previous HPV vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonoginGynaecological solution with polyhexamethylene biguanide, pH 4.0 | Device | Monogin |
Primary outcome
Number of patients with no HPV infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- Background: PubMed 12546268Zanotti 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. doi: 10.3949/ccjm.69.12.948.
- Background: PubMed 20829658Hubner 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.
- Background: PubMed 16479742Marelli 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.
- Derived from this study: PubMed 23009652Gentile A, Gerli S, Di Renzo GC. A new non-invasive approach based on polyhexamethylene biguanide increases the regression rate of HPV infection. BMC Clin Pathol. 2012 Sep 25;12:17. doi: 10.1186/1472-6890-12-17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monogin in people with HPV Infection, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with no HPV infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571141, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.