Evaluation Of The Efficacy Of The Combination Of GLIZIGEN® Oral Solution 1/Day And Vaginal Gel 1/… (NCT05916911) | Clinical Trial Compass
UnknownPhase 4
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)
Spain120 participantsStarted 2023-06-07
Plain-language 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.
Who can participate
Age range30 Years – 65 Years
SexFEMALE
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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.
What they're measuring
1
Rate of resolution of cervical intraepithelial neoplasia grade 1 (CIN-1) caused by High Risk Human Papillomavirus (HR-HPV).