Glizigen® and Oncoxin®-Viusid® in cervical intraepithelial lesions of adult women. Phase II

Phase 2

• Conditions: Cervical intraepithelial lesions; Cervical Intraepithelial Neoplasia; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms

• Registration Number: RPCEC00000271
• Lead Sponsor: aboratorios Catalysis S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

1. Patients that meet the diagnostic criteria.
2. Patients with age =18 years.
3. Patients with residual lesion greater than 3 mm after the initial punch, measurable by video colposcopy and with major changes (Criteria from Rio 2011).
4. Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58).
5. Patients who give their informed consent to participation in writing.
6. Patients who consent to perform the conization according to the study schedule.
7. Patients with normal laboratory parameters within the limits established in the institution (complete blood count, platelets and erythrosedimentation

Exclusion Criteria

1. Patients who have received surgical, ablative, radiant, immunomodulatory or chemotherapy treatment 30 days before recruitment.
2. Patients pregnant or breastfeeding.
3. Patients with acute cervico-vaginal infections.
4. Patients with positive serology known to HIV and/or syphilis.
5. Patients with diseases that compromise the state of consciousness or their possibility of collaboration.
6. Patients with a history of severe allergic history.
7. Patients who are participating in another research.

Study & Design

• Study Type: Interventional
• Study Design: Not specified