CIN1 Clinical Trial
Official title:
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).
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 8, 2025 |
Est. primary completion date | June 4, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Ruber Internacional | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Catalysis SL | Atika Pharma S.L. |
Spain,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of resolution of cervical intraepithelial neoplasia grade 1 (CIN-1) caused by High Risk Human Papillomavirus (HR-HPV). | To assess whether nutritional supplementation with Glizigen® oral solution in combination with topical intravaginal use of Glizigen® vaginal gel promotes resolution of grade 1 cervical intraepithelial neoplasia (CIN-1) caused by High-Risk Human Papillomavirus (HR-HPV) compared to placebo after two months of treatment and 4 months after the end of treatment. It will be measured by biopsy. | 6 months | |
Secondary | Antiviral effectiveness of glizigen against high-risk HPV infection. | To evaluate the efficacy of Glizigen® in improving the negativation rate of high-risk HPV strains (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82) compared to placebo after two months of treatment and 4 months after the end of treatment by PCR. | 2 and 6 months | |
Secondary | Antiviral effectiveness of glizigen against multi high-risk HPV infection. | To assess the efficacy of Glizigen® in improving the negative rate of single or multiple high-risk HPV infections compared to placebo after two months of treatment and 4 months after the end of treatment by PCR. | 2 and 6 months | |
Secondary | Control of progression of Cervical intraepithelial neoplasia from CIN-1 to HSIL/CIN-2/3. | To evaluate the efficacy of Glizigen® in preventing the progression of cervical intraepithelial neoplasia from grade 1 (CIN-1) to grade 2 or 3 (HSIL/CIN-2/3) by colposcopy. | 2 and 6 months | |
Secondary | Grade of safety control | Assess safety at both systemic and local levels using treatment-related adverse effect monitoring questionnaires (YES/NO) | 2 and 6 months | |
Secondary | To Assess patient Tolerance of the study product. | To assess the patient's acceptance of the investigational product, questionnaires will be carried out during follow-up medical visits. Questionnaires are:
- Tolerance questionnaire (YES/NO). |
2 and 6 months | |
Secondary | To Assess patient acceptance of the study product. | To assess the patient's acceptance of the investigational product, questionnaires will be carried out during follow-up medical visits. Questionnaires are:
- Product acceptance questionnaire (YES/NO). |
2 and 6 months | |
Secondary | To Assess patient adherence of the study product. | To assess the patient's acceptance of the investigational product, questionnaires will be carried out during follow-up medical visits. Questionnaires are:
- Treatment adherence questionnaire (YES/NO). |
2 and 6 months | |
Secondary | To Assess adherence to treatment | Assess adherence to treatment by following patients throughout the trial, calculating the average number of patients who stop treatment over the 6 months. | 2 and 6 months |
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