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Spots Global Cancer Trial Database for Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Javier Cortes Bordoy, MD

Affiliation: AEPCC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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