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

Procare Health

Status: Completed

Conditions: HPV Infection; Lesion Cervix

Treatments: Device: papilocare vaginal gel

Study type: Observational

Funder types: Industry

Identifiers

NCT04199260

PAPILOBS-2017-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 263 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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®.

Trial design

263 participants in 1 patient group

Papilocare

Description:

all patients gonna received papilocare treatment as per usual practice.

Treatment:

Device: papilocare vaginal gel