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

 1. Woman over 25 years, whether or not they have been vaccinated against HPV.

 2. 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.

 3. 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®.

 4. Patient who, under that situation, undergoes a colposcopy and has a concordant result
 with cytology.

 5. Patient who has been prescribed treatment with Papilocare® by medical decision prior
 to their participation in the study.

 Exclusion Criteria:

 1. Any situation / alteration / pathology, gynecological or not, which, in medical
 judgment, does not advise or contraindicate the use of Papilocare®.

 2. 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.

 3. Participation in any one clinical trial at present or in the 4 weeks prior to
 inclusion in the study.

 4. Any planned surgery that precludes correct compliance with the guideline.

 5. Known allergies to any of the components of Papilocare®.