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

NCT04199078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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

Sponsors & Collaborators

  • Adknoma Health Research

    collaborator INDUSTRY

  • Procare Health Iberia S.L.

    lead INDUSTRY

Principal Investigators

  • Javier Cortes Bordoy, MD · AEPCC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2024-01-31
Completion
2024-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199078 on ClinicalTrials.gov