Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit

PHASE4RecruitingINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

May 30, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

August 31, 2026

Conditions
Genitourinary Syndrome of Menopause
Interventions
DRUG

Cellular Matrix / A-CP-HA Kit

"For infiltration, a prior preparation of the region with anesthetic cream is performed, procaine 25 mg/g + lidocaine 25 mg/g (Emla 5% cream) in the vulvar area and vaginal introitus. Occlusion of the area with plastic film is performed for 20 minutes. After asepsis and antisepsis, infiltration is performed with mesotherapy needles 31G 4mm, using the technique of superficial point-to-point mesotherapy microinjections, in the vestibule and the first 3 cm of the posterior wall of the vagina."

DRUG

Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel)

Blissel®, Estriol vaginal gel 50 micrograms/g, daily application for 15-21 days in a row, then two times a week for 24 weeks (6 months). Application instructions will be explained to the patients. The gel should be applied in the vagina using an applicator with the marked dose, the full applicator should be inserted into the vagina and emptied, preferably at night.

Trial Locations (1)

08037

RECRUITING

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus, Barcelona

All Listed Sponsors
collaborator

Regen Lab SA

INDUSTRY

lead

Fundación Santiago Dexeus Font

OTHER