The efficacy of the use of Cellular Matrix-BCT-HA (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. - FSD-CEL-2023-11

Santiago Dexeus Font Fundacio Privada0 个研究点目标入组 192 人开始时间: 2024年2月22日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Santiago Dexeus Font Fundacio Privada