PLATELET CONCENTRATE for Genitourinary syndrome of menopause

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- •\tSystemic or local hormonal treatment in the last 3 months"}
• {"criterion_text":"- •\tTamoxifen or Aromatase inhibitor treatments"}
• {"criterion_text":"- •\tVulvovaginal 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)"}
• {"criterion_text":"- •\tContraindication for vaginal estrogen therapy"}
• {"criterion_text":"- •\tWomen with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases."}
• {"criterion_text":"- •\tWomen who have had pelvic surgery within 6 months."}
• {"criterion_text":"- •\tWomen who are unwilling or unable to give informed consent and/or do not comply with the study requirements."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy criteria is the percentage of patients with improved symptomatology. Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) evaluated at 6 months after treatment.","definition_or_measurement_approach":"Improvement defined as a higher score than baseline in the Vaginal Health Index (VHIS) evaluated at 6 months post-treatment; primary endpoint expressed as percentage of patients meeting this improvement criterion."}

Secondary endpoints

• {"endpoint_text":"- Healing percentage defined as percentage of patients scoring ≥ 15 in the VHIS at 6 months after treatment.","definition_or_measurement_approach":"Percentage of patients with VHIS score ≥ 15 at 6 months post-treatment."}
• {"endpoint_text":"- Evolution of Vaginal Health Index at 3-months and 6-months follow-up","definition_or_measurement_approach":"VHIS measured at 3 and 6 months to assess evolution over time."}
• {"endpoint_text":"- Evolution of Vulvar Health Index at 3- and 6-months follow-up","definition_or_measurement_approach":"Vulvar Health Index measured at 3 and 6 months to assess evolution."}
• {"endpoint_text":"- Evolution of vaginal pH at 3- and 6-months follow-up","definition_or_measurement_approach":"Vaginal pH measured at 3 and 6 months."}
• {"endpoint_text":"- Evolution of Vaginal maturation index (vaginal cytology) at 3- and 6-months follow-up","definition_or_measurement_approach":"Vaginal maturation index (cytology) measured at 3 and 6 months."}
• {"endpoint_text":"- Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) will be measured using a 5-cm visual analog scale (VAS) at 3- and 6-months follow-up","definition_or_measurement_approach":"Intensity of specified VVA symptoms measured using a 5-cm VAS at 3 and 6 months."}
• {"endpoint_text":"- Evolution of Female Sexual Distress (FSD) score at 3- and 6-months follow-up","definition_or_measurement_approach":"Female Sexual Distress (FSD) score measured at 3 and 6 months."}
• {"endpoint_text":"- Photographic monitoring at 3- and 6-months follow-up","definition_or_measurement_approach":"Photographic documentation collected at 3 and 6 months for monitoring."}

Methods

• K1_Recruitment arrangements (document present) — recruitment arrangements document
• Email_Cellular Matrix (ESP and CAT) — recruitment email materials available in Spanish and Catalan (files: 'Email_Cellular Matrix_ESP', 'Email_Cellular Matrix_CAT')
• Ficha_Web_CellularMatrix_ESP and Ficha_Web_CellularMatrix_CAT — web information/flyer materials in Spanish and Catalan
• Post_CellularMatrix and Story_CellularMatrix documents — post/story promotional materials (titles indicate use as posts/stories)

Spain

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

15-05-2025

Processing Time Days

423

Number Of Sites

2

Number Of Participants

192

Primary sponsor

Full Name

Santiago Dexeus Font Fundacio Privada

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"FUNDACION SANTIAGO DEXEUS FONT","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Regen Lab SA","duties_or_roles":"Monetary support","organisation_type":""}