Actively Recruiting
Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
Led by Fundación Santiago Dexeus Font · Updated on 2024-07-16
192
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
F
Fundación Santiago Dexeus Font
Lead Sponsor
R
Regen Lab SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 70 years or younger
- Women who are sexually active
- Women reporting symptoms and signs of genitourinary syndrome of menopause (SGM) with a vaginal health index (VHIS) below 15 points
- Women who understand the Spanish language
- Women willing to participate and sign informed consent
You will not qualify if you...
- Use of systemic or local hormonal treatment within the last 3 months
- Current or recent treatment with Tamoxifen or Aromatase inhibitors
- Presence of vulvovaginal pathologies such as condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus
- History of radiation, cervical cancer, other gynecologic cancers, or pelvic radiation
- Active genital infections including bacterial vaginosis, genital herpes, or candida
- Contraindication for vaginal estrogen therapy
- Thrombocytopenia or coagulation disorders
- Systemic infections or sexually transmitted diseases
- Recent cancer treatment of any type
- Connective tissue diseases
- Pelvic surgery within the last 6 months
- Unwillingness or inability to provide informed consent or comply with study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, Spain, 08037
Actively Recruiting
Research Team
A
Antonella de Ponte Davi, MD
CONTACT
I
Ignacio Rodríguez, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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