Trials / Completed
CompletedNCT04199078
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 288 (actual)
- Sponsor
- Procare Health Iberia S.L. · Industry
- Sex
- Female
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2019-09-25
- Primary completion
- 2024-01-31
- Completion
- 2024-06-30
- First posted
- 2019-12-13
- Last updated
- 2024-10-31
Locations
19 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04199078. Inclusion in this directory is not an endorsement.