Last updated: February 6, 2024
Sponsor: Catalysis SL
Overall Status: Active - Recruiting
Phase
2
Condition
Cervical Intraepithelial Neoplasia
Neoplasms
Carcinoma
Treatment
Glizigen® + Ocoxin-Viusid®
Clinical Study ID
NCT03549273
OOS-GLZ-2018
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients that meet the diagnostic criteria.
- Patients with age ≥18 years.
- Patients with residual lesion greater than 3 mm after the initial punch, measurable byvideo colposcopy and with major changes (Criteria from Rio 2011).
- Patients that have a positive test to the oncogenic virus of the human papilloma (16, 18, 31, 33, 45, 52 and 58).
- Patients who give their informed consent to participation in writing.
- Patients who consent to perform the conization according to the study schedule.
- Patients with normal laboratory parameters within the limits established in theinstitution (complete blood count, platelets and erythrosedimentation. In the case ofmale sex (vasectomy, use of condoms) while the treatment lasts.
Exclusion
Exclusion Criteria:
- Patients who have received surgical, ablative, radiant, immunomodulatory orchemotherapy treatment 30 days before recruitment.
- Patients pregnant or breastfeeding.
- Patients with acute cervico-vaginal infections.
- Patients with positive serology known to HIV and/or syphilis.
- Patients with diseases that compromise the state of consciousness or their possibilityof collaboration.
- Patients with a history of severe allergic history.
- Patients who are participating in another research.
Study Design
Total Participants: 62
Treatment Group(s): 1
Primary Treatment: Glizigen® + Ocoxin-Viusid®
Phase: 2
Study Start date:
March 11, 2019
Estimated Completion Date:
January 15, 2025
Study Description
Connect with a study center
Our Lady of Rule No. 52 &/Remedios and Quiroga, Luyano
Havana, 10500
CubaActive - Recruiting
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