Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit
ConditionGenitourinary Syndrome of Menopause
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFundación Santiago Dexeus Font
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cellular Matrix / A-CP-HA Kit
- Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel)
Treatment groups
192 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fundación Santiago Dexeus Font
Lead sponsor
Regen Lab SA
Collaborator
Source ClinicalTrials.gov