Actively Recruiting
Efficacy of Cellular Matrix / A-CP-HA Kit Compared to Local Estrogen Therapy in Women With Genitourinary Syndrome of Menopause: A Randomized Controlled Trial
Led by Fundación Santiago Dexeus Font · Updated on 2024-07-16
192
Participants Needed
1
Research Sites
13 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
Researchers are evaluating the effectiveness of a combination treatment called Cellular Matrix / A-CP-HA Kit, which combines autologous platelet-rich plasma and non-cross-linked hyaluronic acid, compared to standard local estrogen therapy (Blissel, estriol vaginal gel) in women experiencing genitourinary syndrome of menopause (SGM). This randomized, controlled, non-inferiority Phase 4 trial involves 192 menopausal women aged up to 70 years who have been without menstruation for at least 12 months, are sexually active, and have a vaginal health index below 15 points. Participants are randomly assigned to one of two groups: one group receives two doses of the Cellular Matrix / A-CP-HA Kit administered one month apart via mesotherapy microinjections in the vulvar and vaginal area after local anesthetic preparation. The other group receives the standard local estrogen therapy with daily vaginal gel applications for 15-21 days followed by twice-weekly applications for six months. Both groups will be followed for 3 and 6 months after treatment. During the study, participants will have medical history interviews and evaluations of vaginal health using validated scales such as the Vaginal Health Index and Vulvar Health Index, vaginal pH, vaginal maturation index, and Female Sexual Distress score. Symptoms like vaginal burning, itching, dryness, dyspareunia, and dysuria will be recorded using visual analog scales. Follow-up photography, laboratory tests, and monitoring for adverse events and treatment compliance will also be conducted. The primary outcome is the percentage of patients with improved symptoms at 6 months after treatment.
CONDITIONS
Brief Title
Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Sexually active women
- Women reporting symptoms and signs of genitourinary syndrome of menopause with a vaginal health index below 15 points
- Women who understand Spanish
- Women willing to participate and sign informed consent
You will not qualify if you...
- Use of systemic or local hormonal treatment in the last 3 months
- 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 or other gynecologic cancer, pelvic radiation, or active genital infections
- Contraindication for vaginal estrogen therapy
- Women with thrombocytopenia, coagulation disorders, systemic infections, sexually transmitted diseases, recent cancer treatment, or connective tissue diseases
- Pelvic surgery within the last 6 months
- Unwillingness or inability to give informed consent or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive either two doses of Cellular Matrix / A-CP-HA Kit one month apart or local estrogen therapy daily for 15-21 days followed by twice weekly for 24 weeks.
Multiple visits to receive treatments and assessments during the 6 months
Duration - 6 months
Participants are followed for 3 and 6 months after treatment to assess symptom improvement, vaginal health indexes, vaginal pH, vaginal maturation index, symptom intensity, and safety.
Visits at 3 months and 6 months post-treatment
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
I
Ignacio Rodríguez, MSc
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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