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Could a laser ease painful sex for millions of women?

NCT ID NCT05597358

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether high-intensity laser therapy (HILT) can reduce pain during intercourse for women with provoked vestibulodynia, a condition causing severe pain at the vaginal opening. About 145 women with moderate to severe pain will receive either real or sham laser treatments twice a week for six weeks. Researchers will measure changes in pain, sexual function, and quality of life up to six months after treatment.

What this could mean

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

Active substance
High Intensity Laser Therapy (Nd:Yag 1064 nm)
What this could lead to
If effective, this could offer a non-drug, non-surgical option to reduce pain during intercourse for women with provoked vestibulodynia.
What could go wrong
This is a relatively small trial (145 participants) testing a device, and the sham group may also show improvement due to placebo effects. Long-term benefits are not yet known.

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

145 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2025

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 45 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: * Moderate to severe pain (≥ 5/10) at least 90% of the time during sexual intercourse or attempted sexual intercourse for at least 3 months * Provoked vestibulodynia of at least 3 months duration prior to the study and diagnosed by a standardized gynaecologic exam Exclusion Criteria: * Other causes of vulvovaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvovaginal atrophy) * Post-menopausal state * Current pregnancy or pregnancy in the last year * Urogynecological condition (e.g., pelvic organ prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months) * Anterior vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organ prolapse surgery) * Prior use of laser treatments for vulvar pain * Expected changes of medication that could influence pain perception (e.g., analgesic, antidepressant) * Other medical conditions that could interfere with the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centre Hospitalier Universitaire de Québec - Université Laval

    Québec, Quebec, G1V 4G2, Canada

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Exogenia

    Sherbrooke, Quebec, J1L 1C6, Canada

  • Kinatex l'Ormière

    Québec, Quebec, G2B 3K3, Canada

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