Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Cellular Matrix / A-CP-HA Kit

    Drug

    For infiltration, a prior preparation of the region with anesthetic cream is performed, procaine 25 mg/g + lidocaine 25 mg/g (Emla 5% cream) in the vulvar area and vaginal introitus. Occlusion of the area with plastic film is performed for 20 minutes. After asepsis and antisepsis, infiltration is performed with mesotherapy needles 31G 4mm, using the technique of superficial "point-to-point" mesotherapy microinjections, in the vestibule and the first 3 cm of the posterior wall of the vagina.

  • Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel)

    Drug

    Blissel®, Estriol vaginal gel 50 micrograms/g, daily application for 15-21 days in a row, then two times a week for 24 weeks (6 months). Application instructions will be explained to the patients. The gel should be applied in the vagina using an applicator with the marked dose, the full applicator should be inserted into the vagina and emptied, preferably at night.

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Cellular Matrix / A-CP-HA KitExperimental treatment 1 intervention
Group B: Local estrogen therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of patients with improved symptomatology.

Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS)

Time frame
at 6 months after treatment

Secondary outcomes

1

Healing percentage

defined as percentage of patients scoring ≥ 15 in the VHIS

Time frame
at 6 months after treatment
2

Evolution of Vaginal Health Index

Time frame
at 3-months and 6-months follow-up
3

Evolution of Vulvar Health Index

Time frame
at 3-months and 6-months follow-up
4

Evolution of vaginal pH

Time frame
at 3-months and 6-months follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Santiago Dexeus Font

Lead sponsor

Regen Lab SA

Collaborator

Source ClinicalTrials.gov
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