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)

Launched by CATALYSIS SL · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a treatment called Glizigen, which includes an oral solution and a vaginal gel, for women diagnosed with a mild form of cervical cell changes known as Cervical Intraepithelial Neoplasia Grade 1 (CIN-1) caused by high-risk human papillomavirus (HPV). The trial aims to see if this combination treatment can help clear up these precancerous lesions and improve patient outcomes.

To participate, women must be between 30 and 65 years old and have been diagnosed with a high-risk HPV infection confirmed by specific tests. They should also be able to understand the study and agree to take part voluntarily. Participants will receive either the Glizigen treatment or a placebo (a non-active substance) for two months. Throughout the trial, they will be monitored for any changes in their condition. It’s important to note that certain women, such as those who are pregnant or have other significant health issues, will not be eligible to join.

Gender

FEMALE

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.