Investigation to Evaluate PAPILOCARE® Gel Effect on Normalization of Cervix Cytological Alterations Caused by HPV.

Study Overview
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Brief Summary
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Observational clinical study, national, multicentric, prospective, non-comparative, with medical device, under application consistent with CE marking, for the evaluation of Papilocare® effectivness in the normalization of cervix cytological abnormalities caused by HPV.

Detailed Description
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300 patients will be included in approximately 50 Spanish sites. The study comprehend a maximum of 3 visits. At visit 1, patient's writted informed consent will be collected, patient's selection critera will be checked, and patient's medial history data will be collected. At visit 2, 6 months after the first visit, the primary and secondary objectives will be evaluated. For those patients who finish treatment after 6 months, this will be the final visit. Only in that cases where, by usual clinical practice, the doctor indicates patient should continue under treatment, visit 3, wich will take place 12 months after streatment stars, will be the last visit for the patient under study.

Official Title
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Investigación clínica Para la evaluación Del Efecto de PAPILOCARE® en la normalización de Las Alteraciones citológicas Del Cuello Del útero Causadas Por el VPH

Conditions
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HPV Infection, Lesion Cervix

Intervention / Treatment
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* Device: papilocare vaginal gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman over 25 years, whether or not they have been vaccinated against HPV. Able to read and understand the Patient Information Sheet and the Informed Consent form and accept the participation in the study by signing the Informed Consent form. Patient who comes to a visit with a routine cytological result of ASCUS or LSIL and HPV-positive test, of at most 3 months prior to the start of treatment with Papilocare®. Patient who, under that situation, undergoes a colposcopy and has a concordant result with cytology. Patient who has been prescribed treatment with Papilocare® by medical decision prior to their participation in the study. Exclusion Criteria: Any situation / alteration / pathology, gynecological or not, which, in medical judgment, does not advise or contraindicate the use of Papilocare®. Women of childbearing age who do not use effective contraceptive methods, pregnant women, suspected pregnancy, desire for the same within the next 6 months or during breastfeeding. Participation in any one clinical trial at present or in the 4 weeks prior to inclusion in the study. Any planned surgery that precludes correct compliance with the guideline. Known allergies to any of the components of Papilocare®.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Papilocare<br>all patients gonna received papilocare treatment as per usual practice. | Device: papilocare vaginal gel<br>* Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patient who normalized their cytology with concordant colposcopy. | The percentage of patients with normalization of the cytology with concordant colposcopy, at 6 months, and at 12 months if applicable, has been established as the main variable of the study, in order to assess the degree of normalization of cytological alterations. Colposcopy concordant with normalized cytology results will be considered those colposcopic findings classified as normal, non-specific or as abnormal grade 1 (minor) according to the definition of the Nomenclature Committee of the International Federation of Cervical and Colposcopic Pathology (IFCPC). accepted at the Rio World Congress, July 5, 2011. | 6 months | 
| Percentage of patient who normalized their cytology with concordant colposcopy. | The percentage of patients with normalization of the cytology with concordant colposcopy, at 6 months, and at 12 months if applicable, has been established as the main variable of the study, in order to assess the degree of normalization of cytological alterations. Colposcopy concordant with normalized cytology results will be considered those colposcopic findings classified as normal, non-specific or as abnormal grade 1 (minor) according to the definition of the Nomenclature Committee of the International Federation of Cervical and Colposcopic Pathology (IFCPC). accepted at the Rio World Congress, July 5, 2011. | 12 months if applicable | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of treatment | The incidence, nature and severity of adverse events during the 6 months (or 12 months if applicable) of the duration of the treatment will be used to assess the safety and tolerability of treatment. | 6 months | 
| Safety and tolerability of treatment | The incidence, nature and severity of adverse events during the 6 months (or 12 months if applicable) of the duration of the treatment will be used to assess the safety and tolerability of treatment. | 12 months if applicable | 
| Percentage of patient who clear partially or completely the presence of HPV | To evaluate the clearance of HPV, the percentage of patients with total or partial clearance of HPV measured by PCR or genetic diagnostic kits that allow the identification of strains at 6 months (and 12 months if applicable) from the start of treatment. | 6 months | 
| Percentage of patient who clear partially or completely the presence of HPV | To evaluate the clearance of HPV, the percentage of patients with total or partial clearance of HPV measured by PCR or genetic diagnostic kits that allow the identification of strains at 6 months (and 12 months if applicable) from the start of treatment. | 12 months if applicable | 
| Patient's satisfaction degree with the study treatment | Changes appreciated in the Likert scale at 6 months (and at 12 months if applicable) of the start of treatment will be used to evaluate satisfaction degree with the use of Papilocare gel as treatment. | 6 months | 
| Patient's satisfaction degree with the study treatment | Changes appreciated in the Likert scale at 6 months (and at 12 months if applicable) of the start of treatment will be used to evaluate satisfaction degree with the use of Papilocare gel as treatment. | 12 months if applicable |