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Cellular Matrix / A-CP-HA Kit vs Local Estrogen Therapy in Genitourinary Syndrome of Menopause
NCT06425978Phase 4
Key facts
- Status
- Completed
- Start
- May 2024
- Primary completion
- Mar 2026
- Countries
- 1
- Modality
- Cell Therapies, Device-based Delivery
- Conditions
- genitourinary syndrome of menopause (GSM)
01
Overview
Phase 4, randomised, single-blind trial of Cellular Matrix-BCT-HA in genitourinary syndrome of menopause (GSM) (2 arms), sponsored by Fundació Santiago Dexeus Font. Primary endpoint: Percentage of patients with improved symptomatology at 6 months. Started May 2024; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Cellular Matrix / A-CP-HA Kit
Patients receive two doses of Cellular Matrix / A-CP-HA Kit separated by a month.
Local estrogen therapy
Patients receive Blissel (estriol 50 micrograms/g vaginal gel) daily for 15-21 days, then twice a week for 24 weeks.
03
Who it enrols
Sexually active menopausal women ≤70 years old with genitourinary syndrome of menopause and a Vaginal Health Index < 15 points, excluding those with recent hormonal treatments, active genital infections, history of gynecologic cancers, or recent pelvic surgery.
04
Endpoints
Primary
Percentage of patients with improved symptomatology
Secondary
Healing percentage
Vaginal Health Index
Vulvar Health Index
Vaginal pH
Vaginal maturation index
Intensity of VVA symptoms
Incidence of adverse events and serious adverse events
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