Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
Summary
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.
Timeline
- Start
- 2024-05-30
- Primary completion
- 2026-03-23
- Completion
- 2026-03-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estriol | Unknown | — | Other |
| Subject | Platelet Rich Plasma | Other / unclassified | — | Other |
| Subject | non-cross-linked hyaluronic acid | Unknown | 40 mg | Other |
| Background | Lidocaine | Other / unclassified | — | Topical |
| Background | Procaine | Small molecule | — | Topical |
Indications
No indication recorded.