Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit

Официальное название

The Efficacy of the Use of Cellular Matrix / A-CP-HA Kit (Combination of Autologous Platelet-rich Plasma and Non-cross-linked Hyaluronic Acid) Compared to Local Estrogen Therapy (Blissel, Estriol 50 Micrograms/g Vaginal Gel) in Women With Genitourinary Syndrome of Menopause. A Randomized Controlled Trial, With a Second Blind Observer.

Обзор

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.

Подробное описание

This study is a randomized, controlled, non-inferiority trial, with a second blind observer, comparing effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) to the standard line of treatment, local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause (SGM). Duration of the study estimated is 24 months.

A total of 192 menopausal women, with absence of menstruation for at least 12 months, ≤70 years old, that are sexually active and who report symptoms and signs of SGM, with a vaginal health index \<15 points. Patients will be excluded if are in treatment with 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. Women who have had pelvic surgery within 6 months.

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).

Patients will interviewed about their medical history, age of menopause, symptoms related and history of treatments. Evaluation of the Vaginal Health Index (VHIS), Vulvar Health Index (VHI), vaginal pH, and vaginal maturation index (vaginal cytology). The intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia and dysuria) will be measured using a 5-cm visual analog scale (VAS), and a valuation of Female Sexual Distress (FSD) score. Photographic monitoring during all phases of the procedure. Routine laboratory test serology will requested for both groups (valid up to 3 months).

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.

Вмешательства

• Препарат Cellular Matrix / A-CP-HA Kit
  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.
• Препарат Local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel)
  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.

Первичные конечные точки

• Percentage of patients with improved symptomatology. [Срок оценки: at 6 months after treatment]

Вторичные конечные точки (7)

• Healing percentage [Срок оценки: at 6 months after treatment]
• Evolution of Vaginal Health Index [Срок оценки: at 3-months and 6-months follow-up]
• Evolution of Vulvar Health Index [Срок оценки: at 3-months and 6-months follow-up]
• Evolution of vaginal pH [Срок оценки: at 3-months and 6-months follow-up]
• Evolution of Vaginal maturation index (vaginal cytology) [Срок оценки: at 3-months and 6-months follow-up]
• Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) [Срок оценки: at 3-months and 6-months follow-up]
• Incidence of adverse events and serious adverse events [Срок оценки: at 3-months and 6-months follow-up]

Критерии участия

Критерии включения

• 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
• Willing to participate in the study and sign informed consent.

Критерии исключения

• 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.
• Women who have had pelvic surgery within 6 months.
• Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus — Barcelona

Идентификаторы

NCT: NCT06425978 · FSD-CEL-2023-11 · 2023-507200-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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