Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
NCT04002154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2021-02-16
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. All the patients included in the study will be Randomized (1:1:1).
Conditions
- Human Papilloma Virus Infection
- Human Papilloma Virus
- Cervix Lesion
Interventions
- 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
Sponsors & Collaborators
-
Adknoma Health Research
collaborator INDUSTRY -
Procare Health Iberia S.L.
lead INDUSTRY
Principal Investigators
-
Javier Cortés Bordoy, MD · Hospital os Palma de Mallorca
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
- 2015-10-19
- Primary Completion
- 2018-07-31
- Completion
- 2019-02-28
Countries
- Spain
Study Locations
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