NCT04199260

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: Procare Health Iberia S.L. · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• HPV Infection
• Lesion Cervix

Interventions

Type	Name	Description
DEVICE	papilocare vaginal gel	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

Timeline

• Start date: 2018-05-20
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2019-12-13
• Last updated: 2021-08-09

Locations

9 sites across 1 country: Spain