Treatment for Cervical Intraepithelial Neoplasia Grade 1 with Glizigen

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).

This study is testing if a new treatment called Glizigen can help people with early-stage cervical changes caused by HPV get better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 30 Years to 65 Years
• Sex: Female
• Sponsor: Catalysis SL (industry)
• Locations: 4 sites (Madrid and 3 other locations)
• Trial ID: NCT05916911 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Glizigen, an oral solution and vaginal gel containing activated glycyrrhizinic acid, in treating patients with cervical intraepithelial neoplasia grade 1 (CIN-1) caused by high-risk human papillomavirus (HPV). The study is designed as a randomized, double-blind, placebo-controlled trial, aiming to provide evidence on the resolution of biopsy-confirmed CIN-1 lesions. Participants will receive either the Glizigen treatment or a placebo for two months, with outcomes assessed through follow-up examinations. The trial seeks to improve current treatment options for HPV-related precancerous lesions.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 30 to 65 diagnosed with high-risk HPV and biopsy-confirmed CIN-1.

Not a fit: Patients who are pregnant, have other genital infections, or are undergoing immunosuppressive treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for resolving precancerous cervical lesions in women infected with high-risk HPV.

How similar studies have performed: While there have been studies on HPV treatments, the specific combination of Glizigen for CIN-1 is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Women between 30 and 65 years of age.
2. 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.
3. Adequate cultural level and understanding of the clinical study.
4. Agree to participate voluntarily in the study and give written informed consent.

Exclusion Criteria:

1. Failure to meet any of the inclusion criteria.
2. Patient receiving any other product aimed at favouring the resolution of HPV infection.
3. Women with polymenorrhoea or frequent bleeding that makes vaginal administration of the preparation impossible.
4. Patient with immunosuppressive treatment or with other infectious processes in the genitals (e.g. herpes, candida, etc.).
5. Pregnant patients.
6. Participation in a concomitant trial that conflicts with this study.
7. Women with HIV infection.
8. Patients allergic to any component of the investigational product.

Patients who have been vaccinated against HPV before or after the start of the study are eligible to participate in the study, and this should be correctly reflected in the Data Collection Notebook.

Where this trial is running

Madrid and 3 other locations

• Hospital Ruber Internacional — Madrid, Spain (NOT_YET_RECRUITING)
• Hospital Clinico San Carlos — Madrid, Spain (RECRUITING)
• Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
• Hospital Universitario La Paz — Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Pluvio J. Coronado Martín, Dr. — Hospital San Carlos, Madrid
• Study coordinator: David Marquez Soriano, MSc.

Conditions: Papilloma Viral Infection, CIN1, LSIL, Low Grade Squamous Intraepithelial Lesion, Glycyrrhizinic Acid, LSIL/CIN1, Cervical adenocarcinoma, Immunomodulation