120
Participants
Start Date
June 7, 2023
Primary Completion Date
June 4, 2024
Study Completion Date
January 8, 2025
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."
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."
NOT_YET_RECRUITING
Hospital Ruber Internacional, Madrid
RECRUITING
Hospital Clinico San Carlos, Madrid
RECRUITING
Hospital Universitario 12 de Octubre, Madrid
RECRUITING
Hospital Universitario La Paz, Madrid
Collaborators (1)
Atika Pharma S.L.
UNKNOWN
Catalysis SL
INDUSTRY