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Brief Title: Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
Official Title: Ensayo clínico Aleatorizado, Abierto, Paralelo, Controlado, multicéntrico, Para Explorar la Eficacia Del Gel Vaginal Papilocare® en la reparación de la Mucosa Cervical Con Lesiones Causadas Por Virus Papiloma Humano de Alto Riesgo
Study ID: NCT04199078
Brief Summary: Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms.
Detailed Description: Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV-HR. All the patients included in the study will be randomized (1:1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (Papilocare schedule C) Arm D (usual clinical practice-without treatment-). Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. Patients will visit the site into a total of 5 visits throughout the study. Total study duration: 13 months.
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Hospital U. de Donostia, Donostia, Guipuzcoa, Spain
Hospital Universitario HM Puerta del Sur, Móstoles, Madrid, Spain
Hospital Universitari Son Espases, Palma De Mallorca, Mallorca, Spain
Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz De Tenerife, Tenerife, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Complejo Hospitalario Torrecárdenas, Almeria, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Universitari Vall d' Hebron, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
H. U. Reina Sofía, Córdoba, , Spain
Hospital Universitario Virgen de las Nieves, Granada, , Spain
Assir Hospitalet de Llobregat, Hospitalet de Llobregat, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital de Manacor, Manacor, , Spain
H. General Universitario Santa Lucía, Murcia, , Spain
H. R. U. de Málaga / Materno Infantil, Málaga, , Spain
Hospital Virgen de la Macarena, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Hospital Álvaro Cunqueiro, Vigo, , Spain
Name: Javier Cortes Bordoy, MD
Affiliation: AEPCC
Role: STUDY_CHAIR