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Can a woman's own blood platelets ease menopause vaginal symptoms as well as estrogen?

NCT ID NCT06425978

NEW Symptom relief Sponsor: Fundación Santiago Dexeus Font Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

This trial compares a new treatment combining a woman's own platelet-rich plasma with hyaluronic acid against standard local estrogen therapy for genitourinary syndrome of menopause. It enrolls 192 sexually active women up to age 70 who have vaginal dryness, burning, or discomfort and a low vaginal health score. Participants receive either two vaginal injections of the platelet-rich plasma mixture one month apart or a vaginal estrogen gel. Researchers track symptom relief, vaginal health, and side effects over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of a woman's own platelet-rich plasma and non-cross-linked hyaluronic acid, given as vaginal injections
What this could lead to
If it works, this could offer a hormone-free option for women who cannot or prefer not to use estrogen for vaginal symptoms after menopause.
What could go wrong
The trial may find the platelet-rich plasma treatment works no better than standard estrogen therapy. Injections can cause discomfort, bleeding, or infection, and the results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

192 people

The number who actually took part.

Started

May 2024

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

postmenopausal atrophic vaginitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Genitourinary syndrome of menopause

Contacts and locations

Locations

  • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

    Barcelona, 08037, Spain

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