BridgeMD
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.
EU CTIS ID: 2023-507200-31-00
What this study is testing
To establish the effectiveness of the use of Cellular Matrix / A-CP-HA Kit (a 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 (SGM).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- menopausal women, with absence of menstruation for at least 12 months
- • 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.
You likely can't join if
- • 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.
See the full eligibility criteria
- menopausal women, with absence of menstruation for at least 12 months
- • 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.
- • 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.