Evaluation Of The Efficacy Of The Combination Of GLIZIGEN® Oral Solution 1/Day And Vaginal Gel 1/Night For 2 Months In Patients With Cervical Intraepithelial Neoplasia Grade 1 (LSIL/CIN-1) Caused By High-Risk Human Papillomavirus (HPV-AR)
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ClinicalTrials.gov Identifier: NCT05916911 |
Recruitment Status :
Recruiting
First Posted : June 23, 2023
Last Update Posted : February 7, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Papilloma Viral Infection CIN1 LSIL, Low Grade Squamous Intraepithelial Lesion | Dietary Supplement: Glizigen Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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). |
Actual Study Start Date : | June 7, 2023 |
Estimated Primary Completion Date : | June 4, 2024 |
Estimated Study Completion Date : | January 8, 2025 |
Arm | Intervention/treatment |
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Experimental: Glizigen Group
Patients will receive combined treatment with Glizigen® oral solution and Glizigen® vaginal gel for 2 months.
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Dietary Supplement: Glizigen
Treatment initiation: Treatment should be started simultaneously with the appropriate oral and intravaginal formulation after the last menstrual period or immediately in menopausal patients. A total of 60 single doses of intravaginal use and 60 doses of oral solution should be given to each patient. The intravaginal gel should be applied every night before going to sleep by inserting the cannula completely into the vagina and pressing the tube until the entire contents of the tube are poured into the vagina, then removing the cannula from the vagina while continuing to press the tube to avoid retrograde aspiration of the product. Application of the intravaginal gel should be discontinued during days of menstrual bleeding. The oral solution should be administered by drinking 1 vial every morning without interruption for 60 days from the start of treatment. It can be taken either on an empty stomach or with food. |
Placebo Comparator: Placebo Group
Patients will receive combined treatment with Placebo oral solution and Placebo vaginal gel for 2 months.
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Other: Placebo
Treatment initiation: Treatment should be started simultaneously with the appropriate oral and intravaginal formulation after the last menstrual period or immediately in menopausal patients. A total of 60 placebo single doses of intravaginal use and 60 placebo doses of oral solution should be given to each patient. The placebo intravaginal gel should be applied every night before going to sleep by inserting the cannula completely into the vagina and pressing the tube until the entire contents of the tube are poured into the vagina, then removing the cannula from the vagina while continuing to press the tube to avoid retrograde aspiration of the product. Application of the intravaginal gel should be discontinued during days of menstrual bleeding. The placebo oral solution should be administered by drinking 1 vial every morning without interruption for 60 days from the start of treatment. It can be taken either on an empty stomach or with food. |
- Rate of resolution of cervical intraepithelial neoplasia grade 1 (CIN-1) caused by High Risk Human Papillomavirus (HR-HPV). [ Time Frame: 6 months ]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.
- Antiviral effectiveness of glizigen against high-risk HPV infection. [ Time Frame: 2 and 6 months ]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.
- Antiviral effectiveness of glizigen against multi high-risk HPV infection. [ Time Frame: 2 and 6 months ]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.
- Control of progression of Cervical intraepithelial neoplasia from CIN-1 to HSIL/CIN-2/3. [ Time Frame: 2 and 6 months ]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.
- Grade of safety control [ Time Frame: 2 and 6 months ]Assess safety at both systemic and local levels using treatment-related adverse effect monitoring questionnaires (YES/NO)
- To Assess patient Tolerance of the study product. [ Time Frame: 2 and 6 months ]
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).
- To Assess patient acceptance of the study product. [ Time Frame: 2 and 6 months ]
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).
- To Assess patient adherence of the study product. [ Time Frame: 2 and 6 months ]
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).
- To Assess adherence to treatment [ Time Frame: 2 and 6 months ]Assess adherence to treatment by following patients throughout the trial, calculating the average number of patients who stop treatment over the 6 months.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Failure to meet any of the inclusion criteria.
- Patient receiving any other product aimed at favouring the resolution of HPV infection.
- Women with polymenorrhoea or frequent bleeding that makes vaginal administration of the preparation impossible.
- Patient with immunosuppressive treatment or with other infectious processes in the genitals (e.g. herpes, candida, etc.).
- Pregnant patients.
- Participation in a concomitant trial that conflicts with this study.
- Women with HIV infection.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05916911
Contact: David Marquez Soriano, MSc. | 913456902 | david@catalysis.es |
Spain | |
Hospital Ruber Internacional | Not yet recruiting |
Madrid, Spain, 28034 | |
Contact: Alfonso Duque Frischcorn, Dr. | |
Principal Investigator: Alfonso Duque Frischcorn, Dr. | |
Hospital Clinico San Carlos | Recruiting |
Madrid, Spain, 28040 | |
Contact: César A. Gómez Derch, D. | |
Principal Investigator: Pluvio J. Coronado Martín, Dr. | |
Hospital Universitario 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Contact: Carmen Martínez de de Pancorbo González, Dra. | |
Principal Investigator: Victoria Bravo Violeta, Dra. | |
Hospital Universitario La Paz | Recruiting |
Madrid, Spain, 28046 | |
Contact: Rafael Pérez-Santamaría Feijóo, Dr. | |
Principal Investigator: María Serrano Velasco, Dra. |
Principal Investigator: | Pluvio J. Coronado Martín, Dr. | Hospital San Carlos, Madrid |
Responsible Party: | Catalysis SL |
ClinicalTrials.gov Identifier: | NCT05916911 |
Other Study ID Numbers: |
GLI-112 |
First Posted: | June 23, 2023 Key Record Dates |
Last Update Posted: | February 7, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glycyrrhizinic Acid LSIL/CIN1 Cervical adenocarcinoma Immunomodulation |
Virus Diseases Papillomavirus Infections Papilloma Neoplasms Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Infections Urogenital Diseases |
Genital Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Communicable Diseases DNA Virus Infections Tumor Virus Infections Disease Attributes Pathologic Processes |