Genitourinary Syndrome of Menopause Clinical Trial
— CellularMatrixOfficial title:
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.
This study is a randomized, controlled, non-inferiority trial, that will be performed on 192 women on Menopause (absence of menstruation for at least 12 months), with diagnostic of genitourinary syndrome of menopause (SGM) and a vaginal health index <15 points, that are sexually active. Patients will be randomized 1:1, equal number assigned to each of the two treatment groups, to receive treatment with two dose of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) separated for a month, and control group that will receive the standard treatment for SGM, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel). Both groups will be follow-up for 3 and 6 month afther treatment, a blind observer will assess the application of the validated scale (VHIS, VHI), and the investigators will do the FSD, symptom record, maturation index, follow-up photography and evaluation of adverse events and treatment compliance and adherence.
Status | Not yet recruiting |
Enrollment | 192 |
Est. completion date | August 2026 |
Est. primary completion date | May 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundación Santiago Dexeus Font | Regen Lab SA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with improved symptomatology. | Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) | at 6 months after treatment | |
Secondary | Healing percentage | defined as percentage of patients scoring = 15 in the VHIS | at 6 months after treatment | |
Secondary | Evolution of Vaginal Health Index | at 3-months and 6-months follow-up | ||
Secondary | Evolution of Vulvar Health Index | at 3-months and 6-months follow-up | ||
Secondary | Evolution of vaginal pH | at 3-months and 6-months follow-up | ||
Secondary | Evolution of Vaginal maturation index (vaginal cytology) | at 3-months and 6-months follow-up | ||
Secondary | Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) | measured using a 5-cm visual analog scale (VAS) | at 3-months and 6-months follow-up | |
Secondary | Incidence of adverse events and serious adverse events | at 3-months and 6-months follow-up |
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