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Could gentle radio waves ease menopause symptoms?

NCT ID NCT06925139

Symptom relief Sponsor: University of Castilla-La Mancha 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study tests whether a non-ablative radiofrequency treatment can improve vaginal tissue health and reduce symptoms of Genitourinary Syndrome of Menopause (GSM), such as dryness and discomfort, in postmenopausal women. Participants will be randomly assigned to receive either the real treatment or a sham (placebo) procedure over six sessions. The trial will measure changes in sexual function, vaginal health, and quality of life at the end of treatment and three months later.

What this could mean

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

Active substance
Non-ablative monopolar radiofrequency treatment
What this could lead to
If effective, this could offer a non-hormonal, drug-free option to relieve vaginal dryness and discomfort and improve sexual well-being in postmenopausal women.
What could go wrong
This is a small, early-stage trial, and the sham-controlled design means some participants may not experience real benefit. Results may not apply to all women, and the treatment's long-term effects are still unknown.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Started

Jun 2024

Finished

Dec 2024

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

40 to 65 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: * Age between 40 and 65 years. * Postmenopausal women (defined as no menstrual period for at least 12 months). * Experiencing symptoms of Genitourinary Syndrome of Menopause (GSM), such as vaginal dryness, irritation, or discomfort. * Experiencing discomfort or complaints during vaginal penetration. Engaging in sexual activity (at least once a month). * Willing to participate in the study and sign the informed consent form. Exclusion Criteria: * Presenting with active vaginal infections. * Presence of neurological, neoplastic, or sexually transmitted diseases. * Presenting with vulvodynia or vaginismus. * Prolapse grade 2 or higher. * Presenting with altered sensitivity in the pelvic area. * Being a pacemaker carrier or having any device that contains batteries. * Hormonal treatment with estrogens in the last 3 months. * History of radiotherapy in the pelvic area. * Recent pelvic surgery (within the last 6 months). * Being on anticoagulant treatment. * Having undergone laser treatment in the pelvic area or ablative vaginal rejuvenation in the last 6 months. * Cognitive impairment that prevents answering the questionnaires.

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Conditions

The condition(s) this trial relates to.

physiological sexual disorder postmenopausal atrophic vaginitis

As listed by the trial registrant

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

Genitourinary syndrome of menopause Sexual dysfunction Vaginal health

Contacts and locations

Locations

  • University of Castilla-La Mancha

    Toledo, Toledo, 45000, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.