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New pill could ease vulvodynia pain in minutes

NCT ID NCT07391241

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a single dose of the experimental drug pudafensine in 24 women with provoked vestibulodynia, a type of vulvodynia. Researchers measure pain threshold in the vaginal area to see if the drug reduces sensitivity. The trial is double-blind and placebo-controlled to ensure reliable results.

What this could mean

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

Active substance
pudafensine
What this could lead to
If it works, this could point toward a new, fast-acting pain reliever for women with vulvodynia.
What could go wrong
This is a small, early-phase trial with only 24 participants and a single dose. Results may not confirm lasting benefit or apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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: * Participant with vulvodynia (provoked vestibulodynia). Exclusion Criteria: * Women with vulvar pain caused by a specific disorder: 1. Infectious (e.g. recurrent candidiasis, herpes). 2. Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders). 3. Neoplastic (e.g. Paget disease, squamous cell carcinoma). 4. Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma). 5. Trauma (e.g. female genital cutting, obstetrical). 6. Iatrogenic (e.g. postoperative, chemotherapy, radiation). 7. Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), lactational amenorrhea). * History or current diagnosis of significant pelvic floor dysfunction. * Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain or post-partum pelvic pain (to avoid confounding pain outcomes). * History or current diagnosis of pelvic inflammatory disease. * History or current diagnosis of endometriosis. * History or current diagnosis of interstitial cystitis.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MAC

    RECRUITING

    Blackpool, United Kingdom

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