Clinical trial · Interventional
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)
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).
NCT05916911CI-TRIAL-00073720unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CIN1 | — | UNRESOLVED | — |
| LSIL, Low Grade Squamous Intraepithelial Lesion | Low Grade Squamous Intraepithelial Neoplasia | ALIAS | 0.85 |
| Papilloma Viral Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glizigen | Dietary Supplement | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Glizigen Group
- description
- Patients will receive combined treatment with Glizigen® oral solution and Glizigen® vaginal gel for 2 months.
- interventionNames
- Dietary Supplement: Glizigen
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Patients will receive combined treatment with Placebo oral solution and Placebo vaginal gel for 2 months.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Rate of resolution of cervical intraepithelial neoplasia grade 1 (CIN-1) caused by High Risk Human Papillomavirus (HR-HPV).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDJung 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
- BACKGROUNDRositch 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
- BACKGROUNDMunoz 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
- BACKGROUNDBaseman 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
- BACKGROUNDBraaten KP, Laufer MR. Human Papillomavirus (HPV), HPV-Related Disease, and the HPV Vaccine. Rev Obstet Gynecol. 2008 Winter;1(1):2-10. PMID 18701931
- BACKGROUNDde 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
- BACKGROUNDBosch 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.