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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Dexeus Midlife	Barcelona	Spain

Other Sites

Site Name	City	Country	Status
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.05.2024

Trial locations

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.

Investigated diseases:

Genitourinary syndrome of menopause

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 ID:

2023-507200-31-00

Protocol code:

FSD-CEL-2023-11

Trial Phase:

Therapeutic confirmatory (Phase III)

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