New pill could ease vulvodynia pain in minutes
NCT ID NCT07391241
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Vulvodynia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGBlackpool, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can needles quiet chronic pelvic pain?
- Can a laser beam silence chronic vulvar pain?
- A new approach to vulvar pain: could education and behavior change bring relief?
- Could a laser ease painful sex for millions of women?
- New hope for Women's pelvic pain: light and physiotherapy put to the test
- Could sound waves soothe a painful condition? new study tests shock therapy for vulvodynia