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Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
Sponsor: Procare Health Iberia S.L.
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.
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
Key Details
Gender
FEMALE
Age Range
30 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2019-09-25
Completion Date
2024-06-30
Last Updated
2026-09-02
Healthy Volunteers
No
Interventions
Papilocare vaginal gel
Papilocare is a gel vaginally administered by a singledose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
Locations (19)
Hospital U. de Donostia
Donostia / San Sebastian, 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
Almería, 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
L'Hospitalet de Llobregat, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital de Manacor
Manacor, Spain
H. R. U. de Málaga / Materno Infantil
Málaga, Spain
H. General Universitario Santa Lucía
Murcia, Spain
Hospital Virgen de la Macarena
Seville, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain