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)

NCT05916911 | Recruiting Phase 4

• 1 other identifier: GLI-112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Papilloma Viral Infection; CIN1; LSIL, Low Grade Squamous Intraepithelial Lesion

Keywords

Glycyrrhizinic Acid; LSIL/CIN1; Cervical adenocarcinoma; Immunomodulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Antiviral effectiveness of glizigen against high-risk HPV infection.

  2 and 6 months

• Antiviral effectiveness of glizigen against multi high-risk HPV infection.

  2 and 6 months

• Control of progression of Cervical intraepithelial neoplasia from CIN-1 to HSIL/CIN-2/3.

  2 and 6 months

• Grade of safety control

  2 and 6 months

• To Assess patient Tolerance of the study product.

  2 and 6 months

Study Arms (2)

Glizigen Group

EXPERIMENTAL

Patients will receive combined treatment with Glizigen® oral solution and Glizigen® vaginal gel for 2 months.

Dietary Supplement: Glizigen

Placebo Group

PLACEBO COMPARATOR

Patients will receive combined treatment with Placebo oral solution and Placebo vaginal gel for 2 months.

Other: Placebo

Interventions

Glizigen DIETARY_SUPPLEMENT

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.

Glizigen Group

Placebo OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalysis SL: lead
• Atika Pharma S.L.: collaborator

Study Sites (4)

Hospital Ruber Internacional

Madrid, 28034, Spain

NOT YET RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (11)

• Jung WW, Chun T, Sul D, Hwang KW, Kang HS, Lee DJ, Han IK. Strategies against human papillomavirus infection and cervical cancer. J Microbiol. 2004 Dec;42(4):255-66.

  PMID: 15650698 BACKGROUND

• Rositch AF, Koshiol J, Hudgens MG, Razzaghi H, Backes DM, Pimenta JM, Franco EL, Poole C, Smith JS. Patterns of persistent genital human papillomavirus infection among women worldwide: a literature review and meta-analysis. Int J Cancer. 2013 Sep 15;133(6):1271-85. doi: 10.1002/ijc.27828. Epub 2012 Oct 11.

  PMID: 22961444 BACKGROUND

• Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641.

  PMID: 12571259 BACKGROUND

• Baseman JG, Koutsky LA. The epidemiology of human papillomavirus infections. J Clin Virol. 2005 Mar;32 Suppl 1:S16-24. doi: 10.1016/j.jcv.2004.12.008.

  PMID: 15753008 BACKGROUND

• Braaten KP, Laufer MR. Human Papillomavirus (HPV), HPV-Related Disease, and the HPV Vaccine. Rev Obstet Gynecol. 2008 Winter;1(1):2-10.

  PMID: 18701931 BACKGROUND

• de Sanjose S, Brotons M, Pavon MA. The natural history of human papillomavirus infection. Best Pract Res Clin Obstet Gynaecol. 2018 Feb;47:2-13. doi: 10.1016/j.bpobgyn.2017.08.015. Epub 2017 Sep 6.

  PMID: 28964706 BACKGROUND

• Bosch FX, Broker TR, Forman D, Moscicki AB, Gillison ML, Doorbar J, Stern PL, Stanley M, Arbyn M, Poljak M, Cuzick J, Castle PE, Schiller JT, Markowitz LE, Fisher WA, Canfell K, Denny LA, Franco EL, Steben M, Kane MA, Schiffman M, Meijer CJ, Sankaranarayanan R, Castellsague X, Kim JJ, Brotons M, Alemany L, Albero G, Diaz M, de Sanjose S; authors of ICO Monograph Comprehensive Control of HPV Infections and Related Diseases Vaccine Volume 30, Supplement 5, 2012. Comprehensive control of human papillomavirus infections and related diseases. Vaccine. 2013 Dec 31;31 Suppl 7(Suppl 7):H1-31. doi: 10.1016/j.vaccine.2013.10.003.

  PMID: 24332295 BACKGROUND

• Comprehensive Cervical Cancer Control: A Guide to Essential Practice. 2nd edition. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK269619/

  PMID: 25642554 BACKGROUND

• Chan CK, Aimagambetova G, Ukybassova T, Kongrtay K, Azizan A. Human Papillomavirus Infection and Cervical Cancer: Epidemiology, Screening, and Vaccination-Review of Current Perspectives. J Oncol. 2019 Oct 10;2019:3257939. doi: 10.1155/2019/3257939. eCollection 2019.

  PMID: 31687023 BACKGROUND

• Darragh TM, Colgan TJ, Cox JT, Heller DS, Henry MR, Luff RD, McCalmont T, Nayar R, Palefsky JM, Stoler MH, Wilkinson EJ, Zaino RJ, Wilbur DC; Members of LAST Project Work Groups. The Lower Anogenital Squamous Terminology Standardization Project for HPV-Associated Lesions: background and consensus recommendations from the College of American Pathologists and the American Society for Colposcopy and Cervical Pathology. Arch Pathol Lab Med. 2012 Oct;136(10):1266-97. doi: 10.5858/arpa.LGT200570. Epub 2012 Jun 28.

  PMID: 22742517 BACKGROUND

• Kaufman RH. Dysplasia and carcinoma in situ of the cervix. Clin Obstet Gynecol. 1967 Dec;10(4):748-84. No abstract available.

  PMID: 4172733 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Study Officials

• Pluvio J. Coronado Martín, Dr.

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Marquez Soriano, MSc.

CONTACT

913456902; david@catalysis.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 23, 2023
• Study Start: June 7, 2023
• Primary Completion: June 4, 2024
• Study Completion: January 8, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (4)