Evaluación de la Eficacia de la combinación de GLIZIGEN® solución Oral 1/día y Gel Vaginal 1/Noche Durante 2 Meses en Pacientes Con Neoplasia Intraepitelial Cervical de Grado 1 (LSIL/CIN-1) Causada Por el Virus Del Papiloma Humano de Alto Riesgo (VPH-AR).

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

HPV infection can lead to cancer, especially when precancerous lesions have developed and high-risk HPV is present. Glizigen is an oral and intravaginal treatment based on activated glycyrrhizinic acid that has shown potential benefit in patients with HPV. In order to improve the existing evidence, the present study consists of a randomized, double-blind, placebo-compared clinical trial to evaluate the efficacy of combined treatment with Glizigen Oral Solution and Glizigen Vaginal Gel for the resolution of biopsy-confirmed grade 1 cervical intraepithelial neoplasia (CIN-1) in patients with high-risk HPV.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 65
Healthy Volunteers: f
View:

• Women between 30 and 65 years of age.

• Diagnosed with infection with at least one high-risk HPV strain (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82) by PCR test and positive cytology with confirmation of LSIL/CIN-1 by colposcopy and biopsy.

• Adequate cultural level and understanding of the clinical study.

• Agree to participate voluntarily in the study and give written informed consent.

Locations
Other Locations
Spain
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Ruber Internacional
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Contact Information
Primary
David Marquez Soriano, MSc.
david@catalysis.es
913456902
Time Frame
Start Date: 2023-06-07
Estimated Completion Date: 2025-01-08
Participants
Target number of participants: 120
Treatments
Experimental: Glizigen Group
Patients will receive combined treatment with Glizigen® oral solution and Glizigen® vaginal gel for 2 months.
Placebo_comparator: Placebo Group
Patients will receive combined treatment with Placebo oral solution and Placebo vaginal gel for 2 months.
Related Therapeutic Areas
Sponsors
Collaborators: Atika Pharma S.L.
Leads: Catalysis SL

This content was sourced from clinicaltrials.gov