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)

PHASE4RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 7, 2023

Primary Completion Date

June 4, 2024

Study Completion Date

January 8, 2025

Conditions
Papilloma Viral InfectionCIN1LSIL, Low Grade Squamous Intraepithelial Lesion
Interventions
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."

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."

Trial Locations (4)

28034

NOT_YET_RECRUITING

Hospital Ruber Internacional, Madrid

28040

RECRUITING

Hospital Clinico San Carlos, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Atika Pharma S.L.

UNKNOWN

lead

Catalysis SL

INDUSTRY

NCT05916911 - 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) | Biotech Hunter | Biotech Hunter