The efficacy of the use of Cellular Matrix / A-CP-HA Kit (combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) compared to local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause. A randomized controlled trial, with a second blind observer.

Phase 1

Recruiting

• Conditions: genitourinary syndrome of menopause; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2023-507200-31-00
• Lead Sponsor: Santiago Dexeus Font Fundacio Privada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 192

Inclusion Criteria

menopausal women, with absence of menstruation for at least 12 months, •Women =70 years old, •Women that are sexually active, •Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) < 15 points., •Women who understand the Spanish language, •Willing to participate in the study and sign informed consent.

Exclusion Criteria

•Systemic or local hormonal treatment in the last 3 months, •Tamoxifen or Aromatase inhibitor treatments, •Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida), •Contraindication for vaginal estrogen therapy, •Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases., •Women who have had pelvic surgery within 6 months., •Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified