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Study on the Effectiveness of Platelet-Rich Plasma and Hyaluronic Acid vs. Estriol for Women with Menopausal Genitourinary Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of two different treatments for genitourinary syndrome of menopause, a condition that affects many women during menopause and can cause symptoms like vaginal dryness, irritation, and discomfort. The study will compare the use of a treatment called Cellular Matrix / A-CP-HA Kit, which is a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid, with a local estrogen therapy known as Blissel, which contains estriol in the form of a vaginal gel.

The purpose of the study is to determine which treatment is more effective in improving the symptoms of genitourinary syndrome of menopause. Participants in the study will be randomly assigned to receive either the Cellular Matrix / A-CP-HA Kit or the Blissel vaginal gel. The Cellular Matrix / A-CP-HA Kit involves using a gel that is injected, while the Blissel gel is applied vaginally. The study will last for several months, with participants being monitored at different intervals to assess changes in their symptoms and overall vaginal health.

Throughout the study, participants will have their symptoms evaluated using various health indexes and scales to track improvements. The study aims to provide valuable information on the effectiveness of these treatments, potentially offering better options for managing the symptoms associated with menopause. Participants will be observed by a second, independent observer to ensure unbiased results. The study will help in understanding how these treatments can improve the quality of life for women experiencing this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as being a menopausal woman, aged 70 or younger, sexually active, and experiencing symptoms of genitourinary syndrome of menopause.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the vaginal health index (VHIS), which measures the health of the vaginal tissue. A score below 15 points is required for participation.

  3. Step 3

    Treatment allocation

    Participants are randomly assigned to one of two treatment groups: the Cellular Matrix group or the Blissel group.

    The Cellular Matrix group receives a combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid through injection.

    The Blissel group uses a vaginal gel containing estriol, applied locally.

  4. Step 4

    Treatment administration

    The Cellular Matrix treatment involves injections, while the Blissel treatment involves the application of vaginal gel.

    The frequency and duration of administration are determined by the study protocol.

  5. Step 5

    Follow-up assessments

    Follow-up assessments occur at 3 months and 6 months after treatment begins.

    These assessments include evaluations of the vaginal health index, vulvar health index, vaginal pH, and vaginal maturation index.

    The intensity of symptoms such as vaginal burning, itching, dryness, pain during intercourse, and urination discomfort is measured using a visual analog scale.

  6. Step 6

    Final evaluation

    At 6 months, a final evaluation is conducted to determine the percentage of participants with improved symptoms, defined as a higher VHIS score compared to the baseline.

    Additional outcomes include the percentage of participants achieving a VHIS score of 15 or higher and changes in female sexual distress scores.

Who can join the trial?

6 criteria

  • Women who have gone through menopause, meaning they haven't had a menstrual period for at least 12 months.
  • Women who are 70 years old or younger.
  • Women who are sexually active.
  • Women who have symptoms and signs of **genitourinary syndrome of menopause**. This is a condition that affects the urinary and genital areas after menopause. They should have a **vaginal health index** score of less than 15 points. This score is a way to measure the health of the vaginal area.
  • Women who can understand the Spanish language.
  • Women who are willing to participate in the study and agree to sign a document that shows they understand what the study involves, known as **informed consent**.

Who cannot join the trial?

3 criteria

  • Women who are not experiencing genitourinary syndrome of menopause cannot participate. This condition involves changes in the urinary and genital areas due to menopause.
  • Men cannot participate in this study.
  • Individuals who are considered part of a vulnerable population are not eligible. This term refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • Cellular Matrix-BCT-HA

    is a treatment that combines your own blood's platelet-rich plasma with a type of hyaluronic acid that is not cross-linked. This combination is used to help improve symptoms in women experiencing genitourinary syndrome of menopause. The treatment aims to enhance tissue repair and hydration in the affected areas.

  • Blissel

    is a vaginal gel that contains estriol, a form of estrogen. It is used as a local estrogen therapy to relieve symptoms associated with genitourinary syndrome of menopause. The gel helps to restore the natural balance of hormones in the vaginal area, reducing discomfort and improving overall vaginal health.

What is already known about the treatment

  • Blissel

    Blissel is a vaginal gel containing estriol, a form of estrogen, used primarily to treat genitourinary syndrome of menopause. It is applied locally inside the vagina, allowing the hormone to directly alleviate symptoms such as dryness and irritation. Currently, Blissel is well-established in medical literature as an effective treatment for menopausal symptoms affecting the urinary and genital areas. Estriol works by binding to estrogen receptors in the vaginal tissue, promoting the restoration of normal tissue function and moisture. It is classified as a local estrogen therapy.

  • Cellular Matrix-BCT-HA

    Cellular Matrix-BCT-HA is a combination treatment involving autologous platelet-rich plasma and non-cross-linked hyaluronic acid, administered through injection. This innovative therapy is being studied for its potential to treat genitourinary syndrome of menopause. The treatment is still under clinical investigation, with ongoing trials assessing its effectiveness compared to traditional estrogen therapies. The mechanism involves platelet-rich plasma promoting tissue regeneration and hyaluronic acid providing lubrication and hydration. It falls under the category of regenerative medicine therapies.

Investigated diseases

Genitourinary Syndrome of Menopause – This condition occurs in women during menopause due to decreased estrogen levels, affecting the urinary and genital areas. It can lead to symptoms such as vaginal dryness, burning, and irritation, as well as urinary issues like urgency and discomfort. The syndrome progresses as the vaginal tissues become thinner, less elastic, and more prone to injury. These changes can result in discomfort during sexual activity and an increased risk of urinary tract infections. The condition is chronic and can vary in severity among individuals. It is important to address the symptoms to improve quality of life.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2023-507200-31-00Protocol codeFSD-CEL-2023-11Estimated enrolment192 patientsSponsorSantiago Dexeus Font Fundacio Privada

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).